HomeMy WebLinkAbout022323 NYTimes_ _Mask Mandates Did Nothing_ per gold-standard randomized controlled trials________________________________
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https://www.nytimes.com/2023/02/21/opinion/do-mask-mandates-work.html
The Mask Mandates Did Nothing. Will Any Lessons Be Learned?
The New York Times, Feb. 21, 2023 - By
<https://www.nytimes.com/by/bret-stephens>Bret Stephens
The
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/full>most
rigorous and comprehensive analysis of scientific
studies conducted on the efficacy of masks for
reducing the spread of respiratory illnesses
including Covid-19 was published late last
month. Its conclusions, said Tom Jefferson, the
Oxford epidemiologist who is its lead author, were unambiguous.
"There is just no evidence that they" masks
"make any difference,"
<https://maryannedemasi.substack.com/p/exclusive-lead-author-of-new-cochrane>he
told the journalist Maryanne Demasi. "Full stop."
But, wait, hold on. What about N-95 masks, as
opposed to lower-quality surgical or cloth masks?
"Makes no difference none of it," said Jefferson.
What about the studies that initially persuaded
policymakers to impose mask mandates?
"They were convinced by nonrandomized studies, flawed observational studies."
What about the utility of masks in conjunction
with other preventive measures, such as hand
hygiene, physical distancing or air filtration?
"There's no evidence that many of these things make any difference."
These observations don't come from just anywhere.
Jefferson and 11 colleagues conducted the study
for <https://www.cochrane.org/>Cochrane, a
British nonprofit that is widely considered the
gold standard for its reviews of health care
data. The conclusions were based on 78 randomized
controlled trials, six of them during the Covid
pandemic, with a total of 610,872 participants in
multiple countries. And they track what has been
widely observed in the United States: States with
mask mandates fared no better against Covid than those without.
No study or study of studies is ever perfect.
Science is never absolutely settled. What's more,
the analysis does not prove that proper masks,
properly worn, had no benefit at an individual
level. People may have good personal reasons to
wear masks, and they may have the discipline to
wear them consistently. Their choices are their own.
But when it comes to the population-level
benefits of masking, the verdict is in: Mask
mandates were a bust. Those skeptics who were
furiously mocked as cranks and occasionally
censored as "misinformers" for opposing mandates
were right. The mainstream experts and pundits
who supported mandates were wrong. In a better
world, it would behoove the latter group to
acknowledge their error, along with its
considerable
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638642/>physical,
<https://uwaterloo.ca/news/media/research-suggests-mask-wearing-can-increase-struggles-social>psychological,
<https://www.npr.org/2022/01/28/1075842341/growing-calls-to-take-masks-off-children-in-school>pedagogical
and <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8866197/>political costs.
Don't count on it. In
<https://www.youtube.com/watch?v=0y2XV1qox0c&t=4497s>congressional
testimony this month, Rochelle Walensky, director
of the Centers for Disease Control and
Prevention, called into question the Cochrane
analysis's reliance on a small number of
Covid-specific randomized controlled trials and
insisted that her agency's guidance on masking in
schools
<https://www.reuters.com/world/us/us-cdc-stands-by-k-12-school-masking-guidance-states-relax-rules-walensky-2022-02-08/>wouldn't
change. If she ever wonders why respect for the
C.D.C. keeps falling, she could look to herself,
and resign, and leave it to someone else
<https://ncmedsoc.org/cdc-announces-sweeping-changes-to-restore-public-trust/>to
reorganize her agency.
That, too, probably won't happen: We no longer
live in a culture in which resignation is seen as
the honorable course for public officials who fail in their jobs.
But the costs go deeper. When people say they
"trust the science," what they presumably mean is
that science is rational, empirical, rigorous,
receptive to new information, sensitive to
competing concerns and risks. Also: humble,
transparent, open to criticism, honest about what
it doesn't know, willing to admit error.
The C.D.C.'s increasingly mindless
<https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/about-face-coverings.html#:%7E:text=At%20All%20COVID%2D19%20Community,by%20local%20or%20state%20authorities.>adherence
to its masking guidance is none of those things.
It isn't merely undermining the trust it requires
to operate as an effective public institution. It
is turning itself into an unwitting accomplice to
the genuine enemies of reason and science
conspiracy theorists and quack-cure peddlers by
so badly representing the values and practices
that science is supposed to exemplify.
It also betrays the technocratic mind-set that
has the unpleasant habit of assuming that nothing
is ever wrong with the bureaucracy's well-laid
plans provided nobody gets in its way, nobody
has a dissenting point of view, everyone does
exactly what it asks, and for as long as
officialdom demands. This is the mentality that
once believed that China provided a highly
successful model for pandemic response.
Yet there was never a chance that mask mandates
in the United States would get anywhere close to
100 percent compliance or that people would or
could wear masks in a way that would meaningfully
reduce transmission. Part of the reason is
specific to American habits and culture, part of
it to constitutional limits on government power,
part of it to human nature, part of it to
competing social and economic necessities, part
of it to the evolution of the virus itself.
But whatever the reason, mask mandates were a
fool's errand from the start. They may have
created a false sense of safety and thus
permission to resume semi-normal life. They did
almost nothing to advance safety itself. The
Cochrane report ought to be the final nail in this particular coffin.
There's a final lesson. The last justification
for masks is that, even if they proved to be
ineffective, they seemed like a relatively
low-cost, intuitively effective way of doing
something against the virus in the early days of
the pandemic. But "do something" is not science,
and it shouldn't have been public policy. And the
people who had the courage to say as much
deserved to be listened to, not treated with
contempt. They may not ever get the apology they
deserve, but vindication ought to be enough.
--- "No evidence from high quality studies that
... masks make any difference to transmission" ---
https://dailysceptic.org/2023/02/06/dr-carl-heneghan-interviews-dr-tom-jefferson-about-his-major-new-study-showing-masks-have-no-clear-effect/
Dr. Tom Jefferson is the lead author of the newly
updated
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/full>Cochrane
review on the evidence on masks and other
physical interventions for combating respiratory
viruses like SARS-CoV-2. Following the
publication of the review Dr. Jefferson was
<https://trusttheevidence.substack.com/p/tte-podcast-physical-interventions#details>interviewed
by his colleague, Oxford's Professor Carl Heneghan.
TJ: So, a Cochrane review is a study which
synthesises all available studies - all that we
can find or identity - on a particular topic. It
follows a highly structured format and is always
preceded by publication of a protocol. All this
is to minimise the bias. Also, it is extensively
transparent. In this case we are looking at about
300 pages of review. Now, the review called
"Physical interventions to interrupt or reduce
the spread of respiratory viruses" is called in
code A122 for short and I will be using that
acronym simply because it is just too long a
title. So the protocol was first published in
2006 and then the first version was published in
2007, updated in 2009, 2010, 2011, and then 2020,
so this 2023 is the fifth update of this review.
And the reason why we update the reviews is they
are soon out of date if we don't do that,
especially in some fast moving topics.
CH: So it's interesting what's happening here is
that if I look at this you've sort of updated it
for the swine flu pandemic of 2009-2011, and then
there was a large gap until now, when you've had
two updates within a couple of years. And I think
that's quite interesting because there's a lot of
interest in the interventions within this review.
Let me just say what physical interventions are.
They are screening at entry ports, isolation,
quarantine, physical distance, personal
protection, hand hygiene, face masks, glasses and
gargling. That's a lot of interventions but I'm
sure most people out of all those will be really
interested in terms of the masks results, so I'll
come to them later. But first, what did you
include differently in this review compared to
just two or three years ago, what new studies are
included, and what difference has it made?
TJ: The original review had randomised and
non-randomised evidence, but when we got to 2020
we had 67 trials, it had grown exponentially,
with all sorts of physical interventions, so we
decided there was no point in looking at low
quality evidence which was difficult to interpret
and no conclusions could be drawn from, if we had
this massive wealth of trials. So in 2020 we went
forward only with randomised control trials, and
we had 67. We've since added another 11, so we've
got 78 in this update. Forty-three trials
contribute to the metanalysis, that's the
statistical pooling and analysis of the results.
So 11 studies added in this update and the total
of the participants in the whole review is
610,872, so it is a very huge dataset of randomised data.
CH: Interesting, so we've got a significant
amount of randomised controlled data so we'll
come back to your observational data later. But
here's the first result I want to go to, medical
and surgical masks compared to no mask. And what
you say in the results is that we included 12
trials, and it says that wearing masks in the
community probably makes little or no difference
to the outcome of influenza-like illness (ILI) or
COVID-19-like illness compared to not wearing
masks. Now could you just decode what that
actually means, because there are lots of
Covid-like or influenza-like illness, and what
that result means now in the context of this new evidence
TJ. The result means that regardless of what
pathogen or what presenting symptom there is no
evidence from high quality studies that either
medical or surgical masks make any difference to
transmission, which is the whole point of wearing
or not wearing a mask or any of these other interventions like hand-washing.
--- Revealing interview with lead author of new Cochrane review ---
https://maryannedemasi.substack.com/p/exclusive-lead-author-of-new-cochrane
DEMASI: This Cochrane review has caused quite a
stir on social media and inflamed the great mask
debate. What are your thoughts?
JEFFERSON: Well, it's an update from our November
2020 review and the evidence really didn't change
from 2020 to 2023. There's still no evidence that
masks are effective during a pandemic.
DEMASI: And yet, most governments around the
world implemented mask mandates during the pandemic...
JEFFERSON: Yes, well, governments completely
failed to do the right thing and demand better
evidence. At the beginning of the pandemic, there
were some voices who said masks did not work and
then suddenly the narrative changed.
DEMASI: That is true, Fauci went on 60 minutes
and said that masks are not necessary and then weeks later he changed his tune.
JEFFERSON: Same with New Zealand's Chief Medical
Officer. One minute he is saying masks don't
work, and the next minute, he flipped.
DEMASI: Why do you think that happened?
JEFFERSON: Governments had bad advisors from the
very beginning... They were convinced by
non-randomised studies, flawed observational
studies. A lot of it had to do with appearing as
if they were "doing something."
In early 2020, when the pandemic was ramping up,
we had just updated our Cochrane review ready to
publish...but Cochrane held it up for 7 months
before it was finally published in November 2020.
Those 7 months were crucial. During that time, it
was when policy about masks was being
formed. Our review was important, and it should have been out there.
DEMASI: What was the delay?
JEFFERSON: For some unknown reason, Cochrane
decided it needed an "extra" peer-review. And
then they forced us to insert unnecessary text
phrases in the review like "this review doesn't
contain any covid-19 trials," when it was obvious
to anyone reading the study that the cut-off date was January 2020.
DEMASI: Do you think Cochrane intentionally delayed that 2020 review?
JEFFERSON: During those 7 months, other
researchers at Cochrane produced some
unacceptable pieces of work, using unacceptable
studies, that gave the "right answer".
DEMASI: What do you mean by "the right
answer"? Are you suggesting that Cochrane was
pro-mask, and that your review contradicted the
narrative. Is that your intuition?
JEFFERSON: Yes, I think that is what was going
on. After the 7-month delay, Cochrane then
published
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.ED000149/full>an
editorial to accompany our review. The main
message of that editorial was that you can't sit
on your hands, you've got to do something, you
can't wait for good evidence.... it's a complete
subversion of the 'precautionary principle' which
states that you should do nothing unless you have
reasonable evidence that benefits outweigh the harms.
DEMASI: Why would Cochrane do that?
JEFFERSON: I think the purpose of the editorial was to undermine our work.
DEMASI: Do you think Cochrane was playing a political game?
JEFFERSON: That I cannot say, but it was 7 months
that just happened to coincide with the time when
all the craziness began, when academics and
politicians started jumping up and down about
masks. We call them "strident campaigners". They
are activists, not scientists.
DEMASI: That's interesting.
JEFFERSON: Well, no. It's depressing.
DEMASI: So, the 2023 updated review now includes
a couple of new covid-19 studies....the Danish mask
study....and the Bangladesh study. In fact, there
was a lot of discussion about the Bangladesh mask
study which claimed to show some benefit....
JEFFERSON: That was not a very good study because
it was not a study about whether masks worked, it
was a study about increasing compliance for wearing a mask.
DEMASI: Right, I remember there was a
<https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06704-z>reanalysis
of the Bangladesh study showing it had
significant bias....you've worked in this area for decades, you're an expert...
JEFFERSON [interjects]... please do not call me an
expert. I'm a guy who has worked in the field for
some time. That has to be the message. I don't
work with models, I don't make predictions. I
don't hassle people or chase them on social
media. I don't call them names... I'm a scientist. I work with data.
David Sackett, the founder of Evidence Based
Medicine, once wrote a very famous
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1118019/>article
for The BMJ saying that 'experts' are part of the
problem. You just have to look at the so-called
'experts' that have been advising government.
DEMASI: There were so many silly mask policies.
They expected 2yr olds to wear masks, and you had
to wear a mask to walk into a restaurant, but you
could take it off as soon as you sat down.
JEFFERSON: Yes, also the 2- meter rule. Based on what? Nothing.
DEMASI: Did you wear a mask?
JEFFERSON: I follow the law. If the law says I
need to wear one, then I wear one because I have
to. I do not break the law. I obey the law of the country.
DEMASI: Yeah, same. What would you say to people who still want to wear a mask?
JEFFERSON: I think it's fair to say that if you
want to wear a mask then you should have a
choice, okay. But in the absence of evidence, you
shouldn't be forcing anybody to do so.
DEMASI: But people say, I'm not wearing a mask for me, I'm wearing it for you.
JEFFERSON: I have never understood that difference. Have you?
DEMASI: They say it's not to protect themselves,
but to protect others, an act of altruism.
JEFFERSON: Ah yes. Wonderful. They get the Albert
Schweitzer prize for Humanitarianism. Here's what
I think. Your overnight experts know nothing.
DEMASI (laughs)
JEFFERSON: There is just no evidence that they
make any difference. Full stop. My job, our job
as a review team, was to look at the evidence, we have done that.
--- 2023 Cochrane Review itself ---
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/full
<https://www.cochranelibrary.com/>Cochrane
Database of Systematic Reviews - Intervention
Physical interventions to interrupt or reduce the spread of respiratory viruses
Tom Jefferson, Liz Dooley, Eliana Ferroni, Lubna
A Al-Ansary, Mieke L van Driel, Ghada A Bawazeer,
Mark A Jones, Tammy C Hoffmann, Justin Clark, Elaine M Beller
Paul P Glasziou, John M Conly
Version published: 30 January 2023
https://doi.org/10.1002/14651858.CD006207.pub6
Abstract
Background
Viral epidemics or pandemics of acute respiratory
infections (ARIs) pose a global threat. Examples
are influenza (H1N1) caused by the H1N1pdm09
virus in 2009, severe acute respiratory syndrome
(SARS) in 2003, and coronavirus disease 2019
(COVID 19) caused by SARS CoV 2 in 2019.
Antiviral drugs and vaccines may be insufficient
to prevent their spread. This is an update of a
Cochrane Review last published in 2020. We
include results from studies from the current COVID 19 pandemic.
Objectives
To assess the effectiveness of physical
interventions to interrupt or reduce the spread of acute respiratory viruses.
Search methods
We searched CENTRAL, PubMed, Embase, CINAHL, and
two trials registers in October 2022, with
backwards and forwards citation analysis on the new studies.
Selection criteria
We included randomised controlled trials (RCTs)
and cluster RCTs investigating physical
interventions (screening at entry ports,
isolation, quarantine, physical distancing,
personal protection, hand hygiene, face masks,
glasses, and gargling) to prevent respiratory virus transmission.
Data collection and analysis
We used standard Cochrane methodological procedures.
Main results
We included 11 new RCTs and cluster RCTs (610,872
participants) in this update, bringing the total
number of RCTs to 78. Six of the new trials were
conducted during the COVID 19 pandemic; two from
Mexico, and one each from Denmark, Bangladesh,
England, and Norway. We identified four ongoing
studies, of which one is completed, but
unreported, evaluating masks concurrent with the COVID 19 pandemic.
Many studies were conducted during non epidemic
influenza periods. Several were conducted during
the 2009 H1N1 influenza pandemic, and others in
epidemic influenza seasons up to 2016. Therefore,
many studies were conducted in the context of
lower respiratory viral circulation and
transmission compared to COVID 19. The included
studies were conducted in heterogeneous settings,
ranging from suburban schools to hospital wards
in high income countries; crowded inner city
settings in low income countries; and an
immigrant neighbourhood in a high income country.
Adherence with interventions was low in many studies.
The risk of bias for the RCTs and cluster RCTs was mostly high or unclear.
Medical/surgical masks compared to no masks
We included 12 trials (10 cluster RCTs) comparing
medical/surgical masks versus no masks to prevent
the spread of viral respiratory illness (two
trials with healthcare workers and 10 in the
community). Wearing masks in the community
probably makes little or no difference to the
outcome of influenza like illness (ILI)/COVID 19
like illness compared to not wearing masks (risk
ratio (RR) 0.95, 95% confidence interval (CI)
0.84 to 1.09; 9 trials, 276,917 participants;
moderate certainty evidence. Wearing masks in the
community probably makes little or no difference
to the outcome of laboratory confirmed
influenza/SARS CoV 2 compared to not wearing
masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials,
13,919 participants; moderate certainty
evidence). Harms were rarely measured and poorly
reported (very low certainty evidence).
N95/P2 respirators compared to medical/surgical masks
We pooled trials comparing N95/P2 respirators
with medical/surgical masks (four in healthcare
settings and one in a household setting). We are
very uncertain on the effects of N95/P2
respirators compared with medical/surgical masks
on the outcome of clinical respiratory illness
(RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779
participants; very low certainty evidence).
N95/P2 respirators compared with medical/surgical
masks may be effective for ILI (RR 0.82, 95% CI
0.66 to 1.03; 5 trials, 8407 participants; low
certainty evidence). Evidence is limited by
imprecision and heterogeneity for these
subjective outcomes. The use of a N95/P2
respirators compared to medical/surgical masks
probably makes little or no difference for the
objective and more precise outcome of laboratory
confirmed influenza infection (RR 1.10, 95% CI
0.90 to 1.34; 5 trials, 8407 participants;
moderate certainty evidence). Restricting pooling
to healthcare workers made no difference to the
overall findings. Harms were poorly measured and
reported, but discomfort wearing medical/surgical
masks or N95/P2 respirators was mentioned in
several studies (very low certainty evidence).
One previously reported ongoing RCT has now been
published and observed that medical/surgical
masks were non inferior to N95 respirators in a
large study of 1009 healthcare workers in four
countries providing direct care to COVID 19 patients.
Hand hygiene compared to control
Nineteen trials compared hand hygiene
interventions with controls with sufficient data
to include in meta analyses. Settings included
schools, childcare centres and homes. Comparing
hand hygiene interventions with controls (i.e. no
intervention), there was a 14% relative reduction
in the number of people with ARIs in the hand
hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9
trials, 52,105 participants; moderate certainty
evidence), suggesting a probable benefit. In
absolute terms this benefit would result in a
reduction from 380 events per 1000 people to 327
per 1000 people (95% CI 308 to 342). When
considering the more strictly defined outcomes of
ILI and laboratory confirmed influenza, the
estimates of effect for ILI (RR 0.94, 95% CI 0.81
to 1.09; 11 trials, 34,503 participants; low
certainty evidence), and laboratory confirmed
influenza (RR 0.91, 95% CI 0.63 to 1.30; 8
trials, 8332 participants; low certainty
evidence), suggest the intervention made little
or no difference. We pooled 19 trials (71, 210
participants) for the composite outcome of ARI or
ILI or influenza, with each study only
contributing once and the most comprehensive
outcome reported. Pooled data showed that hand
hygiene may be beneficial with an 11% relative
reduction of respiratory illness (RR 0.89, 95% CI
0.83 to 0.94; low certainty evidence), but with
high heterogeneity. In absolute terms this
benefit would result in a reduction from 200
events per 1000 people to 178 per 1000 people
(95% CI 166 to 188). Few trials measured and
reported harms (very low certainty evidence).
We found no RCTs on gowns and gloves, face
shields, or screening at entry ports.
Authors' conclusions
The high risk of bias in the trials, variation in
outcome measurement, and relatively low adherence
with the interventions during the studies hampers
drawing firm conclusions. There were additional
RCTs during the pandemic related to physical
interventions but a relative paucity given the
importance of the question of masking and its
relative effectiveness and the concomitant
measures of mask adherence which would be highly
relevant to the measurement of effectiveness,
especially in the elderly and in young children.
There is uncertainty about the effects of face
masks. The low to moderate certainty of evidence
means our confidence in the effect estimate is
limited, and that the true effect may be
different from the observed estimate of the
effect. The pooled results of RCTs did not show a
clear reduction in respiratory viral infection
with the use of medical/surgical masks. There
were no clear differences between the use of
medical/surgical masks compared with N95/P2
respirators in healthcare workers when used in
routine care to reduce respiratory viral
infection. Hand hygiene is likely to modestly
reduce the burden of respiratory illness, and
although this effect was also present when ILI
and laboratory confirmed influenza were analysed
separately, it was not found to be a significant
difference for the latter two outcomes. Harms
associated with physical interventions were under investigated.
There is a need for large, well designed RCTs
addressing the effectiveness of many of these
interventions in multiple settings and
populations, as well as the impact of adherence
on effectiveness, especially in those most at risk of ARIs.
Authors' conclusions
Implications for practice
The evidence summarised in this review on the use
of masks is largely based on studies conducted
during traditional peak respiratory virus
infection seasons up until 2016. Two relevant
randomised trials conducted during the COVID 19
pandemic have been published, but their addition
had minimal impact on the overall pooled estimate
of effect. The observed lack of effect of mask
wearing in interrupting the spread of influenza
like illness (ILI) or influenza/COVID 19 in our
review has many potential reasons, including:
poor study design; insufficiently powered studies
arising from low viral circulation in some
studies; lower adherence with mask wearing,
especially amongst children; quality of the masks
used; self contamination of the mask by hands;
lack of protection from eye exposure from
respiratory droplets (allowing a route of entry
of respiratory viruses into the nose via the
lacrimal duct); saturation of masks with saliva
from extended use (promoting virus survival in
proteinaceous material); and possible risk
compensation behaviour leading to an exaggerated
sense of security
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0272>Ammann
2022;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0279>Brosseau
2020;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0281>Byambasuren
2021;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0016>Canini
2010;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0282>Cassell
2006;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0290>Coroiu
2021;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0048>MacIntyre
2015;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0351>Rengasamy
2010;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0256>Zamora
2006).
Our findings show that hand hygiene has a modest
effect as a physical intervention to interrupt
the spread of respiratory viruses, but several
questions remain. First, the high heterogeneity
between studies may suggest that there are
differences in the effect of different
interventions. The poor reporting limited our
ability to extract the information needed to
assess any 'dose response' relationship, and
there are few head to head trials comparing hand
hygiene materials (such as alcohol based
sanitiser or soap and water). Second, the
sustainability of hand hygiene is unclear where
participants in some studies achieved 5 to 10
hand washings per day, but adherence may have
diminished with time as motivation decreased, or
due to adverse effects from frequent hand
washing. Third, there is little evidence about
the effectiveness of combinations of hand hygiene
with other interventions, and how those are best
introduced and sustained. Finally, some
interventions were intensively implemented within
small organisations, and involved education or
training as a component, and the ability to scale
these up to broader interventions is unclear.
Our findings with respect to hand hygiene should
be considered generally relevant to all viral
respiratory infections, given the diverse
populations where transmission of viral
respiratory infections occurs. The participants
were adults, children and families, and multiple
congregation settings including schools,
childcare centres, homes, and offices. Most
respiratory viruses, including the pandemic SARS
CoV 2, are considered to be predominantly spread
via respiratory particles of varying size or
contact routes, or both
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0372>WHO
2020c). Data from studies of SARS CoV 2
contamination of the environment based on the
presence of viral ribonucleic acid and infectious
virus suggest significant fomite contamination
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0327>Lin
2022;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0341>Onakpoya
2022b;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0342>Ong
2020;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0377>Wu
2020). Hand hygiene would be expected to be
beneficial in reducing the spread of SARS CoV 2
similar to other beta coronaviruses (SARS CoV 1,
Middle East respiratory syndrome (MERS), and
human coronaviruses), which are very susceptible
to the concentrations of alcohol commonly found
in most hand sanitiser preparations
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0215>Rabenau
2005;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0372>WHO
2020c). Support for this effect is the finding
that poor hand hygiene, despite the use of full
personal protective equipment (PPE), was
independently associated with an increased risk
of SARS CoV 2 transmission to healthcare workers
in a retrospective cohort study in Wuhan, China
in both a high risk and low risk clinical unit
for patients infected with COVID 19
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0350>Ran
2020). The practice of hand hygiene appears to
have a consistent effect in all settings, and
should be an essential component of other interventions.
The highest quality cluster RCTs indicate that
the most effect on preventing respiratory virus
spread from hygienic measures occurs in younger
children. This may be because younger children
are least capable of hygienic behaviour
themselves
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0060>Roberts
2000), and have longer lived infections and
greater social contact, thereby acting as portals
of infection into the household
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0336>Monto
1969). Additional benefit from reduced
transmission from them to other members of the
household is broadly supported by the results of
other study designs where the potential for confounding is greater.
Routine long term implementation of some of the
interventions covered in this review may be
problematic, particularly maintaining strict
hygiene and barrier routines for long periods of
time. This would probably only be feasible in
highly motivated environments, such as hospitals.
Many of the trial authors commented on the major
logistical burdens that barrier routines imposed
at the community level. However, the threat of a
looming epidemic may provide stimulus for their inception.
Implications for research
Public health measures and physical interventions
can be highly effective to interrupt the spread
of respiratory viral infections, especially when
they are part of a structured and co ordinated
programme that includes instruction and
education, and when they are delivered together
and with high adherence. Our review has provided
important insights into research gaps that need
to be addressed with respect to these physical
interventions and their implementation and have
been brought into a sharper focus as a result of
the COVID 19 pandemic. The 2014 WHO document
'Infection prevention and control of epidemic and
pandemic prone acute respiratory infections in
health care' identified several research gaps as
part of their GRADE assessment of their infection
prevention and control recommendations, which
remain very relevant
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0368>WHO
2014). Research gaps identified during the course
of our review and the
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0368>WHO
2014 document may be considered from the
perspective of both general and specific themes.
A general theme identified was the need to
provide outcomes with explicitly defined clinical
criteria for acute respiratory infections (ARIs)
and discrete laboratory confirmed outcomes of
viral ARIs using molecular diagnostic tools which
are now widely available. Our review found large
disparities between studies with respect to the
clinical outcome events, which were imprecisely
defined in several studies, and there were
differences in the extent to which laboratory
confirmed viruses were included in the studies
that assessed them. Another general theme
identified was the lack of consideration of
sociocultural factors that might affect adherence
with the interventions, especially those employed
in the community setting. A prime example of this
latter point was illustrated by the observations
of the use of masks versus mask mandates during
the COVID 19 pandemic. In addition, the cost and
resource implications of the physical
interventions employed in different settings
would have important relevance for low to middle
income countries. Resources have been a major
issue with the COVID 19 pandemic, with global
shortages of several components of PPE. Several
specific research gaps related to physical
interventions were identified within the
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0368>WHO
2014 document and are congruent with many of the
findings of this 2022 update, including the
following: transmission dynamics of respiratory
viruses from patients to healthcare workers
during aerosol generating procedures; a continued
lack of precision with regards to defining
aerosol generating procedures; the safety of
cohorting of patients with the same suspected but
unconfirmed diagnosis in a common unit or ward
with patients infected with the same known
pathogen in healthcare settings; the optimal
duration of the use of physical interruptions to
prevent spread of ARI viruses; use of spatial
separation or physical distancing (in healthcare
and community settings, respectively) alone
versus spatial separation or physical distancing
with the use of other added physical
interventions coupled with examining discrete
distance parameters (e.g. one metre, two metres,
or > two metres); the effectiveness of
respiratory etiquette (i.e. coughing/sneezing
into tissues or a sleeved bent elbow); the
effectiveness of triage and early identification
of infected individuals with an ARI in both
hospital and community settings; the utility of
entrance screening to healthcare facilities; use
of frequent disinfection techniques appropriate
to the setting (high touch surfaces in the
environment, gargling with oral disinfectants,
and virucidal tissues or clothing) alone or in
combination with facial masks and hand hygiene;
the use of visors, goggles or other eyewear; the
use of ultraviolet light germicidal irradiation
for disinfection of air in healthcare and
selected community settings; the use of air
scrubbers and /or high efficiency particulate
absorbing filters and the use of widespread
adherence with effective vaccination strategies.
There is a clear requirement to conduct large,
pragmatic trials to evaluate the best
combinations in the community and in healthcare
settings with multiple respiratory viruses and in
different sociocultural settings. Randomised
controlled trials (RCTs) with a pragmatic design,
similar to the
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0044>Luby
2005 trial or the
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0280>Bundgaard
2020 trial, should be conducted whenever
possible. Similar to what has been observed in
pharmaceutical interventions where multiple RCTs
were rapidly and successfully completed during
the COVID 19 pandemic, proving they can be
accomplished, there should be a deliberate
emphasis and directed funding opportunities
provided to conduct well designed RCTs to address
the effectiveness of many of the physical
interventions in multiple settings and
populations, especially in those most at risk,
and in very specific well defined populations
with monitoring of the adherence to the interventions.
Several specific research gaps deserve expedited
attention and may be highlighted within the
context of the COVID 19 pandemic. The use of face
masks in the community setting represents one of
the most pressing needs to address, given the
polarised opinions around the world, and the
increasing concerns over widespread microplastic
pollution from the discarding of masks
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0356>Shen
2021). Both broad based ecological studies,
adjusting for confounding and high quality RCTs,
may be necessary to determine if there is an
independent contribution to their use as a
physical intervention, and how they may best be
deployed to optimise their contribution. The type
of fabric and weave used in the face mask is an
equally pressing concern, given that surgical
masks with their cotton polypropylene fabric
appear to be effective in the healthcare setting,
but there are questions about the effectiveness
of simple cotton masks. In addition, any masking
intervention studies should focus on measuring
not only benefits but also adherence, harms, and
risk compensation if the latter may lead to a
lower protective effect. In addition, although
the use of medical/surgical masks versus N95
respirators demonstrates no differences in
clinical effectiveness to date, their use needs
to be further studied within the context of a
well designed RCT in the setting of COVID 19, and
with concomitant measurement of harms, which to
date have been poorly studied. The recently
published Loeb RCT conducted over a prolonged
course in the current pandemic has provided the
only evidence to date in this area
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0262>Loeb
2022).
Physical distancing represents another major
research gap which needs to be addressed
expediently, especially within the context of the
COVID 19 pandemic setting as well as in future
epidemic settings. The use of quarantine and
screening at entry ports needs to be investigated
in well designed, high quality RCTs given the
controversies related to airports and travel
restrictions which emerged during the COVID 19
pandemic. We found only one RCT investigating
quarantine, and no trials of screening at entry
ports or physical distancing. Given that these
and other physical interventions are some of the
primary strategies applied globally in the face
of the COVID 19 pandemic, future trials of high
quality should be a major global priority to
be conducted within the context of this
pandemic, as well as in future epidemics with
other respiratory viruses of less virulence.
The variable quality and small scale of some
studies is known from descriptive studies
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0271>Aiello
2002;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0302>Fung
2006;
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0367>WHO
2006b), and systematic reviews of selected
interventions
(<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006207.pub6/references#CD006207-bbs2-0333>Meadows
2004). In summary, more high quality RCTs are
needed to evaluate the most effective strategies
to implement successful physical interventions in
practice, both on a small scale and at a
population level. It is very unfortunate that
more rigorous planning, effort and funding was
not provided during the current COVID 19 pandemic
towards high quality RCTs of the basic public
health measures. Finally, we emphasise that more
attention should be paid to describing and
quantifying the harms of the interventions
assessed in this review, and their relationship with adherence.