Drug dealers are adopting new disguises so they can move around freeley during the coronavirus lockdown, a gang expert has said.

Millions of commuters will be told by Boris Johnson to change their "go to work" times to lengthen the rush hour as the country fires up its economic engines after lockdown.

Comedy sketch also saw Stephen Fry reprise one of his most famous Blackadder characters

Lyft users must self-certify that they are following CDC guidelines related to COVID-19.

Nintendo, Sony, Microsoft seek exemption from threatened Chinese tariffs.

Chelsea have "dropped one" regarding Willian's contract, according to Paul Merson - but the former Arsenal forward also believes the Brazilian winger has been fortunate to avoid criticism for letting his deal run down.

Arsenal have confirmed they are continuing to pay staff in full and do not currently intend to fall back on the government's furlough scheme during the Premier League shutdown.

Uefa have opened the door to domestic league seasons being cancelled due to the coronavirus pandemic.

SC Cambuur head coach Henk de Jong has blasted the decision to declare the Dutch league void, branding it the "biggest scandal" in the country's sporting history.

Alan Pardew insists he will not take a bonus from ADO Den Haag after the Dutch outfit avoided relegation from the Eredivisie.

Crystal Palace chairman Steve Parish has described his reasons for backing the Premier League's 'Project Restart', including wanting to "crown Liverpool champions."

Following the ousters of the Homeland Security secretary and Secret Service director, and the withdrawal of the would-be ICE director’s...

How is it possible to prevent a future pandemic if the origins of the novel coronavirus still remain unclear?

Thousands of Australian expats fear they could be hit with large capital gains tax bills because they've been unable to return home due to COVID-19 travel restrictions, before a June 30 deadline that would have allowed them to sell their property to avoid liabilities.

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The Adelaide Crows will be dealt with in an "educative way rather than a punitive way", police say, after players broke coronavirus quarantine guidelines during a training session.

Germany's leadership, history help stave off catastrophe from the coronavirus crisis — so far

A common cough syrup ingredient has pro-viral properties and should be avoided by people infected by the coronavirus, scientists warn.

A federal court in Los Angeles invalidated an abusive tax shelter scheme engaged in by prominent real estate investors James Thomas and Edward Fox. U.S. District Judge John F. Walter also imposed the maximum penalty - forty percent - allowed by the tax code against them.

Federal officials announced a civil settlement with the state of California Department of Transportation (Caltrans) resolving claims brought by the Presidio Trust and the U.S. Army resulting from Caltrans’ construction and operation of Highway 1 (also known as Park Presidio Boulevard) through the Presidio of San Francisco.

The Justice Department announced today the launch of a live webinar series on avoiding workplace discrimination. The webinars coincide with the 25th anniversary of the passage of the Immigration Reform and Control Act, which created the Office of Special Counsel for Immigration-Related Unfair Employment Practices (OSC).

Today the District Court in the District of Columbia dismissed a challenge filed by the Florida Bankers Association and Texas Bankers Association challenging 2012 amendments to the Department of the Treasury’s interest-reporting regulations.

An owner of an electrical contracting company pleaded guilty today to falsifying disclosure documents required under the Employee Retirement Income Security Act (ERISA), by intentionally under-reporting hours worked by employees to avoid contractually required contributions to employee benefit plans.

Year in and year out, protocol deviations are the most common FDA Site Inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this finding also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.

Why does this keep happening?



The Nature of Protocols
This will come as a surprise to no one: not all protocols are well written.  Important procedures can be hidden in the most obscure places.  Charts depicting Time and Events Schedules are famous for carrying dozens of footnotes that appear nowhere else in the protocol, yet convey important study procedures.   For instance, a pre-dosing column may include a footnote that provides a timeframe for performing a physical exam; a post-dosing footnote might specify the interval at which vitals must be taken.   Failing to follow study procedures compromises subject safety and data integrity; FDA won’t care whether the procedures were in big bold italics or 7-point font.

This, too, may come as no surprise, but not all protocols are error-free.   Information in charts may not match the narrative.  Procedures in Section A may conflict with procedures in Section B.  When the FDA investigator spots an inconsistency, you’ll be asked which of the two conflicting procedures you followed and why.  If you performed procedure A only because you didn’t even notice there was a B, it will be clear you didn’t read the protocol as thoroughly as you needed to.  The FDA investigator may become concerned that your study execution differed from the sponsor’s intention.  This is not a concern you want to trigger.

For these reasons, it’s imperative that study staff read and understand the protocol.  Study team members need to ask questions about anything they’re unsure of, seek clarification on protocol inconsistencies, and get responses that satisfy before starting the study.   A PowerPoint overview is not sufficient training.

One more irksome attribute of protocols that can make them difficult to follow -- they change.  While most study sites allocate time and resources for initial protocol training, many lack a plan for training staff on protocol amendments.   A disproportionate number of protocol deviations occur in amended procedures, and it’s often because staff members have been insufficiently trained on them.  (And when you do train on protocol amendments, don’t forget to document it.)

Deviation Temptation
A protocol is not a suggestion; PIs cannot substitute their own judgment for prescribed procedures, no matter how well-intentioned the departure.  The protocol for a psoriasis study might call for the PI to perform a series of punch biopsies, very invasive procedures.  After the first biopsy, an empathetic PI might be tempted to skip a second if he observes the plaque is clearing up; the drug is working.  But this would be a protocol deviation.  The protocol for another study might preclude the use of a particular drug, even though the drug is routinely used throughout the practice to treat a symptom that a study participant is exhibiting.  But the study protocol trumps standard of care; prescribing the drug would be a protocol deviation.

A PI who feels she must deviate from the protocol for some reason must obtain prior approval, since failure to follow the protocol can jeopardize the reliability of the study data, if not subject rights and safety.



Deviations Happen
So you’ve thoroughly read the protocol, you’ve asked your questions and received the necessary clarifications, you’ve trained your staff on the protocol and its amendments, and you do your best to follow them.

Despite all your preparation and vigilance, protocol deviations happen.  They just do.  And when they do, here are two don'ts.

(1) Don’t panic.

(2) Don’t let an FDA investigator find them first.
Take the time to fully document any protocol deviations.  Be sure to record why they happened, how they were corrected, and what was submitted to the IRB.

[Note: IRBs have different requirements about what types of protocol deviations should be communicated.  Out-of-window visits are common and are frequently considered too minor to report.  But nothing’s black and white.  If the missed visit resulted in missed doses, that would probably change the calculus. The PI needs to determine whether to notify the IRB, and if no submission is thought necessary, it’s a good idea to document why not.]

_______________________________________________________________

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

by Annie Waldman

Last September, over pancakes at a diner in central Massachusetts, Molly Baldwin told her husband, Jonathan, they were going to have a baby. He cried into his coffee mug, elated and a little surprised. They had only been trying for about a week, and they had yearned for a summer baby, ideally in June, which would enable their parents to spend more time with their first grandchild.

“We thought we had the best timing,” she said.

But as the novel coronavirus began to spread through the country this year, Baldwin realized in early March that it was only a matter of time before the virus hit her town, Fitchburg, and the nursing home where she’s a social worker. Her patients would be among the most vulnerable: Some had battled addiction, many had experienced homelessness and most were elderly. Flu seasons were always hard on her patients, and she dreaded the havoc a more lethal disease would wreak.

Baldwin also worried about her baby. She spent hours looking up the prenatal effects of COVID-19, and the lack of evidence-based research concerned her. She called her obstetrician, who cautioned that because of the unknowns, she should consider working from home to limit her exposure to the virus.

So Baldwin made a plan for when COVID-19 arrived at her nursing home: She would swap shifts with a colleague to work fewer hours and request to work from home, as many of her duties are paperwork or computer-based.

She would work from the comfort of her kitchen table. She would avoid catching the virus. She would keep visiting her doctor until it was time to deliver, her belly swelling with a baby girl she knew was healthy and safe.

None of it, not a single thing, would go according to plan.

Baldwin said her supervisor and the human resources representative from the facility verbally agreed in mid-March to let her work from home. (Baldwin spoke with ProPublica on the condition that her workplace not be named; ProPublica contacted her employers with questions for this story.)

Then, on April 16, one of the residents at her facility tested positive for the virus. Baldwin sought testing at a walk-in clinic, and the results came back negative. But when she called her obstetrician’s office, she got a warning: If she continued to work at the facility, potentially exposing herself to the virus, they would not allow her to enter their office for prenatal appointments unless she could prove with a test, before each visit, that she was negative for COVID-19.

She understood their caution; her job was beginning to feel at odds with her pregnancy. It was time for her work-from-home plan to go into action.

She called her employer and asked to start the accommodations she had requested the month before. But they told her that now the plan would not be feasible, she said. Other pregnant employees were continuing to work at the facilities, and she would have to as well, she said she was told.

“The services provided at a nursing home do not typically allow for remote working,” a company spokesperson told ProPublica. “However, we have made changes to accommodate our staff whenever possible, provided there is no impact on patient care.”

After finding out her request to work from home would not be granted, Baldwin panicked. “I’m not even a mom yet,” she said. “This is my first baby, and I already feel like I’m doing everything wrong.”

---

Baldwin is one of dozens of pregnant workers who ProPublica has heard from who are navigating the risks of COVID-19 while in the field of health care.

“There are plenty of pregnant women across the country who are trying to figure out what to do to protect themselves, given the uncertainty,” said Emily Martin, vice president for education and workplace justice at the National Women’s Law Center. “If you feel like you can’t do your job because there aren’t certain accommodations and you feel like you’re at risk, it’s difficult to see where to go next.”

About half of the states have laws that allow pregnant women to request reasonable accommodations, including Massachusetts, Martin said.

According to the Massachusetts Pregnant Workers Fairness Act, signed into state law in July 2017, employers must grant reasonable accommodations to their pregnant employees that allow them to continue to do their job, “unless doing so would impose an ’undue hardship’ on the employer.” An employer also “cannot make an employee accept a particular accommodation if another reasonable accommodation would allow the employee to perform the essential functions of the job.”

Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists have stated that based on the data available, pregnant women do not face a higher risk of infection or severe morbidity related to COVID-19. That said, both the CDC and ACOG have suggested that health care facilities may want to consider reducing the exposure of pregnant health care workers to patients with confirmed or suspected COVID-19, if staffing permits.

“In the overwhelming majority of pregnancies, the person who is pregnant recovered well with mild illness,” said Dr. Neel Shah, an obstetrician and assistant professor at Harvard Medical School, echoing the current guidance. But, he cautioned, there is a lot we still don’t know about how the virus impacts bodies, let alone those that are pregnant. “We can’t say that it’s completely safe — we don’t know.”

---

Baldwin and her husband went through their options.

She couldn’t quit because they needed her paycheck. They had a mortgage, student loans and a new baby on the way. She also loved her job and cared deeply for her patients, whom she wanted to continue to serve. Her employer, trying to manage understaffing, had discouraged employees from taking time off, she said. She didn’t want to take any additional sick days, because she needed to save them for her maternity leave.

They decided that she would have to return to work.

Her employer told her to wear a mask and gloves, use hand sanitizer and remain in her small, boxy office, which has three desks for four people. Though she didn’t have contact with the residents, her office mates still did.

Even though she was scared, she tried to stay optimistic. “I was grateful for what I had because I have friends that are out of work right now,” she said. But she remained perplexed about why her requests had been denied. “I was sitting in my office doing work that would have easily been done from a laptop on my kitchen table.”

The company spokesperson did not respond to a question about whether it had originally given Baldwin verbal approval to work from home. When asked why she couldn’t have done the same work remotely, he said, “Based on your questions, our HR and Risk Management are anticipating action and would prefer to not comment at all.”

The next day, the Massachusetts National Guard delivered testing kits to the nursing home, and every resident was checked for the virus. When the results came back, at least 22 residents and 20 other staff members tested positive.

“We are conducting cleanings and infection control measures multiple times per day, with extra focus on high touch areas,” the company spokesperson said. “We screen and take the temperature of anyone entering our building, and we have increased monitoring of our residents.”

Public data shows the facility has more than 30 cases among residents and staff, the maximum number that the state reports publicly.

“I thought if I just keep working, stay in my office, use hand sanitizer, wear my mask, go home and shower right away, disinfect my clothes, then I will be fine, and I can keep my baby safe, and I can shed all this guilt,” she said.

Then on April 24, two of her office mates texted to tell her they had the virus.

And that morning, she’d felt a tickle in her throat.

---

“I know I’m positive,” she thought to herself, as she left work midday and drove to a CVS drugstore testing site an hour away that was offering free rapid tests for front-line and health care workers. Hundreds of cars were already lined up.

She waited alone in her Jeep Wrangler for three hours, wearing her mask as required, which muffled her nagging cough. She shifted around constantly, to keep blood from pooling in her swelling feet. At the front of the line, she received a 6-inch cotton swab, wedged it deep in her nasal cavity, and returned it to the technicians. They directed her into a side parking lot, and 30 minutes later, she got a phone call with her results.

“We’re sorry to tell you that you’re positive,” the voice on the line told her. Baldwin’s mind stalled, engulfed in a wave of anxiety, which gave way to seething frustration.

“This was so preventable,” she said. “Now here I am, 33 weeks pregnant and positive. My most important job is to keep the baby safe, and my actual job wasn’t making that happen.”

When she called her co-workers and supervisor to tell them she tested positive, she said they were “all very caring and compassionate.” They told her to stay home for at least a week, or until her symptoms subsided. The Families First Coronavirus Response Act requires most employers to provide their workers with two weeks of paid leave if the employee is quarantined or experiencing COVID-19 symptoms. Baldwin said she would have to exhaust her sick days first; she’d been saving them for her maternity leave. Her husband, who works as a correctional officer at a county jail, was allowed to take 14 days of paid leave to tend to his wife, without using his own sick days.

She could no longer go to her normal obstetrician for in-person appointments, and instead, she would have to rely on telemedicine. Her doctor connected her with an obstetrician specializing in COVID-19 cases, with whom she planned to meet this week.

---

Last Saturday, Baldwin’s mother had planned to throw her daughter a baby shower. She had invited 50 of their closest friends to celebrate at a new restaurant and had ordered dozens of pink favors from Etsy.

Because of the stay-at-home order, her shower morphed into a drive-by celebration, where her friends and family passed by her house, honking their horns and holding celebratory signs, balloons and streamers. They dropped gifts in front of her house, including first aid kits and a handsewn pink mask for an infant.

Her symptoms have, so far, been relatively mild, similar to a normal flu: headaches, a stuffy nose, a sore throat and muscle pains. She’s spent most of the past week resting in bed and taking baths to soothe her body aches. While taking care of Baldwin, her husband has also contracted the virus and is experiencing severe body aches as well.

In addition to her disappointment that the hypnobirthing and breastfeeding classes she had signed up for are canceled, her time in quarantine is now filled with anxious questions about how the disease may impact her baby.

Will the stress of this experience damage her baby neurologically? Will her baby be born early? Will she have to deliver by cesarean section to relieve pressure on her body and lungs, like so many stories she had read? Will she have to be secluded from her baby for days or weeks after birth? And what if her own symptoms worsen?

“This is our first baby, and it was so planned and wanted,” she said. “But had we known this awful thing would happen, would we have tried when we did?”

---

A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.

To read the whole article click on the headline

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

Apr 21, 2020

The last time the United States faced a big, hard-to-track threat, we ended up with the Patriot Act and a mass-surveillance program that still rankles. This time, how do we use technology to combat the novel coronavirus without creating elements of a police state?

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 3, 2020

“Those who do not study history are condemned to repeat it.”  And the rest of us are condemned to repeat George Santayana.

Will the Coronavirus Recession of 2020 be V-shaped?  Or U-shaped?  If we fail to heed the lessons of history it is likely to be W-shaped, with incipient recovery followed by successive relapses into sickness and recession.

As has been widely noted, we would have been better prepared to cope with the Covid-19 pandemic in the first place if everyone had paid more attention to the past history of epidemics. Be that as it may, the world is now deep into the pandemic and its economic consequences, the most severe such events since the interwar period, 1918-1939.  As decision-makers in every country contemplate their next steps, they would do well to ponder the precedents of that interwar period.

May 4, 2020

“Those who cannot remember the past are condemned to repeat it,” George Santayana famously quipped in 1905. It is a phrase that has been repeated for over a century, but rarely heeded. As Covid-19 decimates the global economy, our understanding of history could be the difference between a V- or U-shaped recession and a W-shaped one, in which incipient recovery is followed by successive relapses.

As recently as March, V-shaped recoveries in individual economies seemed plausible. Once infections and deaths had peaked and begun to decline, the logic went, people would eagerly return to work. The economic activity might even get an extra boost, as consumers released pent-up demand.