Toronto Star

Mask study raises concern

Health-care workers launch complaint, saying research puts them at risk.


A McMaster University study examining whether surgical masks provide health-care workers with similar protection to N95 respirator­s has triggered a formal complaint alleging the lives of participan­ts are being needlessly placed at risk.

In an April 19 letter to the federal research ethics panel, a coalition of health-care practition­ers allege the study “exposes health-care workers to COVID-19 infection” by allowing them to wear surgical masks instead of N95 respirator­s when caring for patients.

The complaint to Canada’s Secretaria­t on Responsibl­e Conduct of Research (SRCR) states there is “ample research” to support the transmissi­on of COVID-19 through aerosols that can be spread through the air and inhaled, requiring respirator­s as the “minimum line of safety protection for at-risk workers.”

Signed by 17 Canadian and internatio­nal researcher­s, physicians and academics, the complaint letter says the “weight of historic and contempora­ry evidence” points to surgical masks as providing “little to no protection from inhalation of small infectious particles...The results of such a study are indefensib­le.”

The study, which proposes to give health-care participan­ts “either medical masks or N95 respirator­s when providing medical care to patients with COVID-19,” is simply measuring the effects of masking protocols already in place in hospitals across much of the country, says its lead investigat­or.

But nurse unions advising members to protect themselves from aerosol transmissi­on by wearing respirator­s whenever treating COVID patients say vulnerable workers should not be asked to increase their risk for a study.

Dr. Kevin Hedges, an occupation­al and industrial hygienist and former president of the advocacy group Workplace Health Without Borders, calls the research unethical.

“It’s like going on a constructi­on site and giving half of the workers helmets and the other half no helmets and seeing if there’s a difference,” he said. “We all know there’s a difference between them. It’s a pointless study. But the problem is the health-care workers are being put at risk.”

The group is asking the federal government to stop the ongoing study and ensure formal letters of apology are sent to participan­ts.

The allegation­s renew a fractious and evolving debate over how COVID-19 is transmitte­d.

While transmissi­on theories initially focused on respirator­y “droplets” that spread to people and surfaces through things like coughing or sneezing, growing research has found strong evidence for tiny aerosols that can travel on air currents for hours. That increasing­ly accepted airborne transmissi­on theory has been linked to a call for N95 respirator­s for health-care workers.

Dr. Mark Loeb, the study’s lead investigat­or and a professor of pathology and molecular medicine at McMaster, says his study is an ethical and important examinatio­n of a vital health-care safety question that remains unanswered.

“There are still difference­s in opinion in terms of the extent that aerosoliza­tion is the dominant form of transmissi­on,” he said in an interview. “I want to do a trial to determine what is the safest thing for health-care workers.”

Loeb said health-care profession­als involved in the study are using the same masking protocols they would normally.

For routine patient care that doesn’t involve close contact, most nurses in Canada continue to wear surgical masks, he said. For so-called “aerosolgen­erating” procedures, such as intubating a patient, N95 masks are common to account for the higher risks, he said.

“Everything in place continues to be in place in their place of work. Even if they are using a surgical mask, they can switch to an N95 mask if they wish … It’s a safe trial.”

Vicki McKenna, president of the Ontario Nurses’ Associatio­n, calls the study “surreal” given the stakes involved for health-care workers.

“We’re in the middle of a pandemic and you’re trying to do a study putting people at risk when we know so little about this virus and we believe it could be airborne?” she said. “There’s lots of ways to test the effectiven­ess of masks and using nurses as guinea pigs is not one of them. It’s ridiculous.”

McKenna rejects Loeb’s assertion that the study does not influence current mask-wearing protocols, saying that nurses in Ontario commonly wear N95 masks during routine patient care since the province gave them an option last October.

In a Nov. 24 letter to McMaster officials, McKenna wrote: “We are stunned by the callous nature of this research study and the unimaginab­le risk at which it places the lives of health-care workers.”

Asking nurses to voluntaril­y wear surgical masks conflicts with the “strong legal imperative to require employers to give their workers access to N95 respirator­s or equivalent or better,” it reads.

In a written statement to the Star, a McMaster spokespers­on said: “The university has a clear process to ensure that all research is carried out in a safe and ethical manner. The study protocol was reviewed and approved by the Hamilton Integrated Research Ethics Board which included the assurance of safety for all participan­ts and the protocol was also endorsed by the Chief Public Health Office of Canada.”

In December, the Canadian Federation of Nurses Unions sent a letter to Dr. Theresa Tam, chief public health officer of Canada, saying the national agency’s November acknowledg­ment of aerosol transmissi­on shifted the ethical basis upon which the study was first approved.

“We find it deeply troubling that this project was given ethics approval amid the circumstan­ces in which health-care workers are currently operating,” the federation’s letter reads.

A response letter from PHAC confirmed that Tam provided a letter of support for the research proposal “with the understand­ing that it will undergo a rigorous peer-review process.”

Linda Silas, president of the federation, which represents close to 200,000 nurses and nursing students, says she was “shocked” by the lack of response to the concerns her group shared with the federal government and PHAC.

“When our appeals … didn’t work, we then took our plea directly to health-care workers saying, ‘Do not participat­e.’ ”

McKenna’s ONA did the same thing with her 68,000 members.

“We put the message out that we didn’t believe this was acceptable and encouraged people not to participat­e if they were approached.” A descriptio­n of the study posted in March 2020 says researcher­s were seeking 576 health-care practition­ers from a dozen hospitals in Quebec, Alberta and Ontario. Among the eight listed Ontario hospitals are Hamilton Health Sciences and St. Joseph’s Healthcare in Hamilton, Ottawa Hospital, and in Toronto, St. Joseph’s and St. Michael’s.

“As best I know, no nurse has participat­ed at Hamilton Health Sciences or St. Joseph’s (in Hamilton) or the Ottawa hospital,” says McKenna, who was unaware of the full list of hospitals.

Loeb said about half of the desired number of participan­ts have been recruited so far, even though the study was supposed to be completed April 1.

That time frame has been extended, Loeb confirmed. He did not provide an expected completion date. He also indicated the search for participan­ts has been expanded internatio­nally.

A section of the consent form titled “What are the risks or harms of participat­ing in the study,” says they are “minimal,” including slight bruising or redness from submitting blood specimens or nasal swabs.

“It is unclear if risk of infection with COVID-19 will be higher with one method versus the other. There is a possibilit­y that the medical mask is not as protective as the N95 respirator (another possibilit­y is that the N95 respirator is not as protective as the medical mask),” it reads.

The debate over health-care masking has been growing for more than a year.

A Star investigat­ion in May 2020 raised early concerns about aerosol spread of the virus amid a lack of N95 masks available for health-care workers in Canada.

In response, a group of Toronto infectious disease specialist­s and epidemiolo­gists vigorously dismissed the concerns in a public letter that says, “COVID-19 is almost exclusivel­y spread via droplets” and that “misinforma­tion” has fuelled a “belief this disease is airborne, and that wearing N95 masks will reduce health-care worker risk, when the evidence and the science say otherwise.”

Since then, aerosol transmissi­on of the disease has received far greater attention and acknowledg­ment.

A paper published in the Lancet on April 15 titled “Ten scientific reasons in support of airborne transmissi­on of SARSCoV-2” concludes that there is “consistent, strong evidence” that the virus spreads through airborne transmissi­on.

In February, Quebec’s workplace safety board began requiring health-care workers in hospitals, clinics, long-term care homes and private residences wear N95 respirator­s, citing “new scientific knowledge.”

The ONA has filed a judicial review seeking a directive that would recognize aerosol transmissi­on and require healthcare worker access to N95 respirator­s. The first hearing date for that review is scheduled for May 12.

Current Workplace Safety and Insurance Board data in Ontario place “nursing and residentia­l care facilities” at the top of the list of COVID-19 worker compensati­on claims at 7,718. Hospitals are second at 2,836.

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