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A Conversation Guide: COVID-19 Medical Research Terms Defined

Posted on Jun 22, 2020 in Affiliates, Community Benefit, Expanding Access, Innovation, Quality, Research, Safety, Scroll Images

Investigational Treatments
Researchers conduct clinical trials to study investigational or experimental treatments to determine if potential new treatments, such as drugs and medical devices, can safely and effectively prevent or treat disease or other health concerns. Clinical trials of potential new drugs can also provide information on how much of a drug is needed, what benefits and side effects may occur, and how drugs or other interventions impact individuals differently based on age, gender, and race/ethnicity.

Drug and medical device development is most commonly conducted in several phases:
Preclinical tests: Before clinical trials involving humans are conducted, potential treatments are first assessed in preclinical research. Such preclinical research assesses the features of a test or treatment. For example, the research may aim to learn if a device is harmful to humans. Another aim may be to learn more about the chemical composition of a drug. In preclinical studies of vaccines, researchers give the vaccine to animals to see if it produces an immune response.

Phase 0: These studies are the first clinical trials conducted in humans. They aim to learn how a drug is processed in the body and how it affects humans. In these trials, a very small dose of a drug is given to about 10 to 15 people.

Phase 1: These studies assess the safety of a drug or device. This phase of testing, which can take several months to complete, usually includes a small number of healthy study participants (20 to 100 people). Phase 1 studies aim to better understand the effects of the drug or device on humans. For drug studies, this may include how the drug is absorbed, metabolized or excreted in humans, and what side effects may occur as dosing increases. In Phase 1 studies of vaccines, researchers give the vaccine to a small number of people to test safety and dosage, and confirm that it stimulates the immune system.

Phase 2: Phase 2 studies test the effectiveness of a drug or device over several months to two years, and involve up to several hundred patients. Most Phase 2 drug studies are randomized trials where one group of patients receives an experimental drug, while a second “control” group receives a standard treatment or placebo. Often these studies are “blinded,” meaning neither the study participants nor the researchers know who has received the experimental drug or other intervention. With such an approach, comparative information can be generated about the relative safety and effectiveness of the new drug, device or other intervention.

In Phase 2 studies of vaccines, researchers give the proposed vaccine to hundreds of people split into groups to see if the vaccine acts differently among the various groups of study participants. These trials seek to further test the proposed vaccine’s safety and ability to stimulate the immune system.

Phase 3: These studies involve randomized and blind testing in several hundred to several thousand study participants. This large-scale testing, which can last several years, seek to provide the manufacturer of a proposed treatment with a thorough understanding of the effectiveness of the drug or device, as well as the benefits and the possible adverse reactions or side effects. Once Phase 3 is complete, a pharmaceutical company or medical device company may use the data generated and collected from the performance of the Phase 3 study in order to request FDA approval to market the drug or medical device.

In Phase 3 studies of vaccines, researchers give the vaccine to thousands of people and wait to see how many become infected, compared with study volunteers who received a placebo. These trials can determine if the vaccine protects against COVID-19, for example.

Phase 4: These studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer use. Pharmaceutical and medical device companies have several objectives at this stage: to compare a treatment with other similar treatments already in the market; monitor the treatment’s long-term effectiveness and impact on a patient’s quality of life, and; to determine the cost-effectiveness of a particular approved treatment relative to other traditional and new therapies.

In Phase 4 studies of vaccines, regulators in each country review the trial results and decide whether or not to approve the vaccine. During a pandemic, a vaccine may receive emergency use authorization before formal approval.

Expanded Access
Sometimes called “compassionate use,” expanded access is a potential route for patients with a serious or life-threatening disease to gain access to an investigational drug or device where there is no comparable, alternative therapy, but the patient’s clinician, in coordination with the pharmaceutical or medical device company, believes that the particular treatment may be beneficial to the patient if applied. Expanded access use of a drug or device is done outside of the clinical trial context, but, as with clinical trials, also involves regulatory and reporting obligations to the FDA.

As of June 2020, expanded access is one pathway advancing the use of convalescent plasma for patients with serious COVID-19, who are not otherwise eligible for or who are unable to participate in clinical trials.

Emergency Use Authorization
An Emergency Use Authorization (EUA) is one way the FDA makes certain medical products (drugs, tests, vaccines) available quickly during a pandemic. The FDA may issue an EUA to provide access to these products when there are no adequate, approved options.

Under an EUA, in an emergency, the FDA provides access to the public based on the best available evidence, without having all the evidence that would normally be needed for full FDA approval. The FDA balances the potential risks and benefits of the medical products based on the data currently available.

EUAs can be revised or revoked by the FDA at any time as the agency continues to evaluate the available data and patient needs during a public health crisis like a pandemic.

“Off-Label” Use of an Approved Drug
After the FDA approves a drug for a certain disease or health condition, doctors may prescribe the drug in clinical care for an use not specifically listed in the approved labeling (i.e., “off-label”) based on the physician’s medical judgment, but recognizing that the FDA has not assessed the safety or effectiveness of such use.

For example, in April 2020 the FDA acknowledged that certain off-label use of the antimalarial drugs hydroxychloroquine and chloroquine had been prescribed by physicians for the treatment of COVID-19. These drugs have been FDA approved for use in treating malaria, but not for widespread use in treating COVID-19 since no formal clinical trials had been previously conducted to examine the efficacy of the drugs for this purpose. The FDA thus did not have data necessary to support an approved use of hydroxychloroquine or chloroquine.

“FDA Approved”
The FDA is the national regulatory agency that among its various duties, approves drugs, medical devices, and vaccines based on clinical data and other information showing that the treatment is safe and effective for its intended use and in compliance with federal quality standards. The “stamp of approval” is provided when the FDA determines that the benefits of a drug, device of other medical product outweigh its risks.

Learn more about clinical research and the phases of clinical trials.

Juneteenth: A Day for Celebration, Education and Connection

Posted on Jun 18, 2020 in Health Equity, Scroll Images, Uncategorized

Juneteenth is the oldest-known celebration commemorating the end of slavery in the United States. Although the Emancipation Proclamation of 1863 declared all slaves free, it was not until two and a half years later, on June 19,1865 that Union soldiers landed in Galveston, Texas and informed slaves that the Civil War had ended and slavery had been abolished. The news kicked off widespread celebrations across the state.

Sutter Health joins in the celebration of this historic event, but the realities of today are sobering.

One hundred and fifty-five years later, racism still exists in our country and freedom for Black Americans remains elusive. The killing of George Floyd is an example of the systemic racial injustice Black Americans have endured for centuries in the U.S.

“Sutter Health affirms that Black Lives Matter and encourages us all to speak up and raise our voices against racism and to advocate for systemic change,” says Stephen Lockhart, M.D., Ph.D., chief medical officer and executive sponsor for Sutter’s Multicultural Inclusive Resource Group.

Sutter Health President and CEO Sarah Krevans says, “Our Sutter values compel us to speak out against inequity in healthcare and injustice and racism in our society. Within Sutter, our organization has an unyielding commitment to equity, diversity and inclusion, and we work to embed it into our culture. We know there is more to be done and are committed to it.”

Sutter takes pride in caring for one of the most diverse patient populations in our nation. Dr. Lockhart is leading a national effort to advance health equity and address health disparities that exist for patients in healthcare across the country. “We know that inequities exist in healthcare and we’re focused on being a national leader to address those disparities and improve healthcare for all. To the extent we are able to make a difference, we have a moral obligation to do so.”

It’s Time to Get the Care You’ve Been Waiting For

Posted on Jun 18, 2020 in Affiliates, Alta Bates Summit Medical Center, Mills-Peninsula Health Services, Quality, Safety, Scroll Images, Uncategorized, Wellness, Women's Services

OAKLAND, CALIF. — California is slowly reopening, but like so many unknowns with COVID-19, it’s unclear how long our return to routine will last.

“A surge in virus spread and infected patients could occur this fall or winter,” says Bill Isenberg, M.D., chief quality and safety officer for Sutter Health. “If this happens, and overlaps with the normal flu season, there could be a significant strain on healthcare services.”

With this in mind, medical experts agree that if you had an appointment postponed or canceled due to COVID-19, now is the time to reschedule it.

Norma Lester-Atwood, RTRM, is a mammographer at the Carol Ann Read Breast Health Center at Alta Bates Summit Medical Center in Oakland, so she’s well-versed in the importance of catching breast cancer early. Lester-Atwood is typically right on schedule for her own mammogram, but this spring, shelter-in-place orders delayed her mammogram by two months. As soon as she could, she had the screening procedure and she’s glad she did, because her mammogram and a subsequent biopsy revealed a Stage 0 (non-invasive) tumor in one of her breasts. After a lumpectomy to remove the tumor, Lester-Atwood feels she is well on her way to recovery.

“As a mammographer, I’ve always told my patients that it’s important to come in every year for a mammogram because I’ve seen patients who developed fast-growing tumors between screenings,” says Lester-Atwood. “And now because of my personal experience, I’ve seen the other side of the coin and I have even more reason to encourage patients to get their regularly scheduled mammograms.”

Timing is Everything
As Lester-Atwood’s experience shows, timing is everything when it comes to staying healthy. Getting cancer screenings at the recommended intervals can help spot early signs of abnormal cell division or tumor growth before it turns into advanced cancer.

Public health department-mandated cancellation of elective procedures and many routine appointments earlier this year caused many screenings to be delayed, which may, unfortunately, have serious repercussions for some people.

Because of the importance of cancer screenings to maintaining good health, Sutter-affiliated clinicians track annual completion of mammograms, says Isenberg. “We estimate that of every 200 mammograms, one patient’s is suspicious for breast cancer and needs further attention. Because so far to date 4,000 – 5,000 people have postponed mammograms, that means approximately 20-25 cancers may have gone undiagnosed.”

The 0.5 percent detection rate for mammograms is roughly the same for colon and cervical cancer screening, says Isenberg, so similar undiagnosed cancers are likely for these diseases. “Mammograms and screenings for other cancers such as skin or prostate cancer, as well as preventative care are all important to keep on top of,” he says. “And although we often think of cancer as a disease that people get at a later stage in life, cancer can strike at any age. In fact, some hormone-sensitive cancers grow more rapidly in younger patients, so having regularly scheduled Pap test or mammograms can be lifesaving.”

“Some women don’t realize that mammograms are needed regardless of your family history, because most women with breast cancer have no family history or other identifiable risk factors,” says Harriet B. Borofsky, M.D., medical director of breast imaging with Mills-Peninsula Medical Center in San Mateo, Calif., part of the Sutter Health not-for-profit integrated network of care.

Screening for colorectal, prostate and lung cancers are also vital. “Simply put, screening saves lives,” says Borofsky. “Delayed screenings can postpone detection of cancer, which may translate into needing more intensive treatment and a more difficult path for patients.”

Taking Steps to Protect Patients and Staff
Catching up on care is one of the most important things you can do to protect your health. All Sutter imaging centers have resumed some level of cancer screening services, or are preparing to resume soon, and each has taken steps to protect patients and staff from exposure to viruses. These steps include:

Mandatory Masking – Staff, patients and visitors must wear masks at all times.
Isolation – Anyone with COVID-19 symptoms is isolated from waiting areas, patient rooms, entrances and spaces the general population uses.
Cleaning – Our teams have increased the frequency of cleaning and disinfecting in all spaces.
Screening – Everyone is screened for signs and symptoms of COVID-19 before entering our care.
Contact-Free Check-In – Skip the front desk and check in from your mobile device at some locations through Hello Patient, a new feature on My Health Online.

These protocols apply to all visits to our outpatient care centers, including scheduled office visits, radiology, lab and walk-ins to Urgent Care.

Resources to Help with Health Insurance Disruption

Health insurance coverage can be disrupted by wage or job loss, but there are options that provide access to important cancer screenings, even if you’ve lost your normal source of coverage.

In California, the Every Woman Counts program covers mammograms and cervical cancer screening for women with no or limited insurance who meet other eligibility criteria. To learn more, patients can call 1(800)-511-2300.

Other options include extending employer-based coverage through COBRA and CalCOBRA, shopping for plans and applying for premium assistance through Covered California, or applying for and qualifying for Medi-Cal. Charity care and financial assistance options may also be available. You can learn more about these options by visiting sutterhealth.org/coverage-options.

Art Out of Turmoil: Mission Care Center Converts Plywood into Community Murals

Posted on Jun 17, 2020 in People, Scroll Images

SAN FRANCISCO – Sutter Pacific Medical Foundation (SPMF) invited a dozen local artists along with employees and their family and friends to craft murals on its temporarily boarded-up windows at 899 Valencia Street Care Center, a group of family and internal medicine clinicians who see children and adults.

In response to recent racial justice protests in the Mission District, the primary care clinic, which sits at the corner of Valencia Street and 20th Street in the heart of the Mission, erected plywood boards to protect the facility and ensure it would remain open and able to provide healthcare for patients.

The clinic provides routine health care services, including preventive care, women’s health, chronic condition management, and treatment for acute illnesses for this diverse community, and has remained open during the COVID-19 pandemic.

“The project’s goal has been to create a safe space for artists to express themselves in support of recent urgent civil issues, which directly impact this community,” said SPMF Care Center Manager Andrea Contreras.

Local artists painted colorful murals on 16 large floor-to-ceiling wooden panels. Themes focused on essential workers, Black Lives Matter and health in the community. Mediums ranged from graffiti to paint to vinyl wall wraps with messages like “Essential Workers for President!” and “We are with you 899.”

“Our center understands there are many challenges in the struggle for equality and firmly believes that well-being, safety and quality-of-life must include quality health care,” said Robert Nordgren, M.D., CEO of the Sutter Bay Medical Foundation, who attended the painting.

The Mission District has a proud tradition of creating murals to reflect the current culture and changing times. As onlookers passed by the artworks in progress, many stopped to praise the bold emerging themes and to share their happiness over the new colorful—and powerful—displays.

“While these boards are temporary, we hope this gesture will be a long-lasting force for bringing the community together to heal,” said Dr. Nordgren.

PPE Donations: Like Mother, Like Daughter

Posted on Jun 17, 2020 in Affiliates, Alta Bates Summit Medical Center, People, Safety, Scroll Images

Jiaqi Yu

OAKLAND, Calif. –It’s not quite the family business, but 15 year old Jiaqi Yu has definitely learned how to make connections and obtain much-needed PPE like masks and shoe coverings by watching her mom, Minfen Ding, RN.

Minfen Ding, RN

In April, Yu’s mother facilitated donation of 13,000 masks and other PPE to Sutter’s Alta Bates Summit Medical Center in Oakland where she works as an oncology nurse. Now Yu has helped make connections and facilitate the delivery of 20,000 masks to the hospital.

“I am very proud of Jiaqi. She cares about the safety of our staff and is able to advocate for our hospital,” says Ding.

The College Preparatory School ninth grader says she was inspired to facilitate the donation of masks by watching her mom’s efforts to gather PPE to protect her colleagues.

“I believe that every medical worker on the frontlines deserves the best equipment,” says Yu. “They are all working hard to protect us, but they need protection too, and I wanted to do what I can to help them.”

Yu facilitated donation of the masks, which she secured from the Fountain Project Foundation, an East Bay non-profit working to help people with no health insurance obtain medical care.

Feeling Safe Amid Uncertainty

Posted on Jun 16, 2020 in Quality, Scroll Images, Sutter Davis Hospital

Stephanie Myers & Garry Douglas, Sweden 2019

Garry Douglas is one who can appreciate a journey. He made his way from just outside the Saginaw Chippewa Indian Reservation near Mount Pleasant, Michigan, to Northern California in the early 1970s. He explored the majesty and mystery of national forests and grasslands through his job with the U.S. Forest Service. He travels the world with his wife, Stephanie Myers, to visit friends he’s made over the years. But nothing could have prepared Douglas for the journey he endured earlier this year: a diagnosis of COVID-19.

Douglas spent a week in Glasgow, Scotland, visiting a longtime friend before heading to Cambridge, England, for several days and then making the trek to London. He returned home to Winters, a small town in rural Yolo County, on March 16. He started to feel unwell a few days after returning, plagued by headaches and fatigue. After consulting with his physician, Carla Kakutani, M.D., Douglas visited an urgent care clinic where his flu test came back negative. His symptoms took a turn for the worse in the days ahead. The 68 year-old felt disoriented. Shaking with chills one moment, his temperature ratcheting up to 103 degrees the next. On March 30, he came to Sutter Davis Hospital’s emergency department and was eventually admitted.

For Douglas, his recollection of the journey pauses here for a moment. His exhaustion, coupled with the eventual sedation he went under in the intensive care unit, suspends time for him. But Myers picks up the tale – albeit secondhand. She wasn’t allowed to be with Douglas in the hospital because of the visitor limitations in place to limit the spread of coronavirus and protect patients and staff. Conversations with emergency department staff, and Carly Grovhoug, M.D., Myers’ primary care doctor, who works closely with Dr. Kakutani, act like the mile markers toward an unknown destination.

But the path eventually became clearer. The Sutter Davis ICU team was always responsive to her calls any time of the day to check on his status. Social worker Katie Tenerelli was also a “godsend” according to Myers.

“She talked through a lot of things with me, told me what he looked like,” she said.

Myers was eventually able to see him firsthand through the power of video visits with the help of staff as well. Initially, since Douglas was on a ventilator, verbal communication was limited at best.

“He could hear me, but he was out of it. I’d say, ‘Garry, open your eyes,” she said with a laugh.

A visit to Lake Superior, 2019

By the end of the second week, Douglas’ condition improved. He was growing more alert and eventually was removed from the ventilator. He always considered himself relatively healthy and active. But now his activity was limited to “belly band” exercises. Technically known as high-frequency chest wall oscillation, the procedure helps improve lung function. While connected to an airway clearance device, Douglas laid on his back with an elastic band around his abdomen that vibrated 25 minutes at a time. There were also the short-distance field trips—within his room—from the bed to the chair and back again.

“I was a total weakling since I hadn’t moved in two weeks,” he said.

But Douglas was moved by how the thoughtful gestures of Sutter Davis’ ICU staff continued. From the simplest acts of grabbing him coffee to hanging up photos from he and Myers’ wedding or some from their travels made him feel more comfortable, more at home.

Once Douglas was healthy and strong enough to go home, the entire Sutter Davis Hospital team pulled out all the stops. From the second floor on down to the first, through the lobby and even out the hospital’s main entrance, employees lined up for what seemed like miles to applaud his recovery and wish him well.

Douglas was taking his own victory lap to the cheers of adoring fans. It was a salute suited for a hero. And in the eyes of the Sutter Davis team, he was. At this unprecedented time with a lot of unknowns and unpredictability with the virus, he was just as much of a symbol of hope and perseverance to them as they had been for him.

Douglas and Myers are back at home now, adjusting to the new normal. Douglas had a fairly detailed after-care plan that included a home health care nurse and physical therapy visits twice a week coordinated through Sutter Care at Home. Plus, he had a series of other medications and vitamins to take. He is making progress every day and relishes the comforts of home, but reflects back fondly on those he met at Sutter Davis Hospital throughout this uncharted territory of COVID-19.

“It was such a good feeling…to me it just showed how caring they were,” he said.