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Mon, Nov 6 8:00am · Larger-dose opioid prescriptions not coming from emergency departments, study shows

Opioid prescriptions from the emergency department (ED) are written for a shorter duration and smaller dose than those written elsewhere, shows new research led by Mayo Clinic. The study, published today in the Annals of Emergency Medicine, also demonstrates that patients who receive an opioid prescription in the ED are less likely to progress to long-term use.

This challenges common perceptions about the ED as the main source of opioid prescriptions, researchers say.

“There are a few things that many people assume about opioids, and one is that, in the ED, they give them out like candy,” says lead author Molly Jeffery, Ph.D., a researcher in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. “This idea didn’t really fit with the clinical experience of the ED physicians at Mayo Clinic, but there wasn’t much information out there to know what’s going on nationally.”

To study 5.2 million opioid prescriptions written for acute – or new-onset – pain across the U.S. between 2009 and 2015, the researchers used the OptumLabs Data Warehouse, a database of de-identified, linked clinical and administrative claims information. None of the patients in the study had received an opioid prescription for the previous six months. This made it easier to compare doses by eliminating patients who built up a tolerance to the drugs.

Read more about this study on the Mayo Clinic News Network, and find a Mayo Clinic Minute video on the subject here.

Mon, Oct 16 8:00am · Mayo Clinic scientific director named to national opioid stewardship team

Researchers across the United States are studying ways to reduce opioid use. In the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, scientists are using evidence-based research to find the ideal dose for each patient, and examining where higher-dose prescriptions may be coming from. Now, one of the center’s scientific directors, Elizabeth Habermann, Ph.D., has been named a member of the National Quality Forum’s National Quality Partners Opioid Stewardship Action Team.

Dr. Habermann will work with leading institutions, physicians and researchers looking to combat what the Centers for Disease Control and Prevention (CDC) has called an opioid epidemic. In the last 15 years, the number of Americans receiving an opioid prescription and the number of deaths involving overdoses have roughly quadrupled, according to the CDC. More than 41 people per day died from a prescription opioid overdose in 2015.

The Opioid Stewardship Action Team will look at ways of managing pain while reducing opioid addiction. The group will release a “playbook” in March 2018 at the National Quality Forum’s annual conference.

Dr. Habermann is the senior author of a study published in July in the Annals of Surgery that examined the prescribing practices after surgery at Mayo Clinic. The study, which highlighted a variation in prescribing within specific surgical procedures and among its three campuses, led to evidence-based opioid prescribing guidelines for several departments.

Dr. Habermann and colleagues are now surveying patients after surgery to see which types of patients are receiving excess opioids, and to determine how well they’re managing their pain.

Researchers in the Mayo Clinic Kern Center for the Science of Health Care Delivery also conducted a study that found opioid prescriptions written in the emergency department are written for a shorter duration and smaller dose than those written in other medical settings. That challenges a common perception, the researchers said.

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Mon, Aug 21 9:14am · Shared decision making should encourage conversations, researchers contend

Shared decision making involves educating patients so they can work with clinicians to make decisions about their care. Mayo Clinic researchers advocate for tools that promote a conversation during the visit (called conversation aids), and not simply provide information to the patients beforehand for them to make a decision themselves (referred to as patient decision aids).

To improve quality and reduce health care spending at a population level, state and federal agencies have begun requiring shared decision making tools for certain procedures and tests. With legal and financial incentives, the Centers for Medicare and Medicaid Services and others aim to move the industry toward value-based care.

But do shared decision making tools, which involve educating patients so they can work with clinicians to make decisions about their care, improve care? Mayo Clinic is helping answer that question.

Researchers in the Mayo Clinic Knowledge and Evaluation Research Unit published an editorial in JAMA on Aug. 15 on shared decision making. The researchers advocate for tools that promote a conversation during the visit (called conversation aids), and not simply provide information to the patients beforehand for them to make a decision themselves (referred to as patient decision aids). The researchers contend that patient decision aids can burden patients with having to decline their clinicians’ recommendations, but conversation aids directly encourage patient-clinician dialogue and a joint decision.

“While some organizations simply distribute decision aids to patients and consider the job done, we believe that patients are best served by an unhurried consultation,” says senior author Juan Brito Campana, M.B.B.S., medical director of the Mayo Clinic Shared Decision Making National Resource Center.

The Mayo researchers cite research, also published Aug. 15 in JAMA, which looked at 105 clinical trials involving more than 31,000 patients. That research found that shared decision making tools are associated with improved patient knowledge of options and outcomes, and do not consistently reduce the use of invasive or expensive treatments. More importantly, they couldn’t find strong evidence that these tools promote conversations between patients and clinicians. In fact, only five of the clinical trials – all conducted by the Mayo Clinic Shared Decision Making National Resource Center – sought to promote these conversations and observed what happened during these visits.

“Future research must discover new ways to promote meaningful conversations between patients and clinicians,” says co-author Marleen Kunneman, Ph.D., of the Knowledge and Evaluation Research Unit.

The Mayo Clinic researchers argue that conversation aids could achieve the stated goal – patients and clinicians working together to decide which option best fits the patient – while imposing the smallest footprint as possible on patients’ lives.

“Clinicians want to truly appreciate what is going on with their patients and how best to move forward,” Dr. Brito Campana says. “Shared decision making is one way to achieve this goal.”

The Mayo Clinic Shared Decision Making National Resource Center advises clinicians and researchers in the design, evaluation and implementation of shared decision making tools, helping Mayo lead in this field. The center has developed conversation aids for chest pain, diabetes medication, and osteoporosis, among many others.

Dr. Brito Campana is a Kern Health Care Delivery Scholars Program alumnus within the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

Thu, Aug 3 7:56am · Mayo researchers seek to manage pain while minimizing opioid prescriptions

Mayo Clinic researchers are studying data on opioid prescriptions after surgery. The goal is the best possible outcome for patients with minimal exposure to opioids.

In the last 15 years, the number of Americans receiving an opioid prescription and the number of deaths involving overdoses have roughly quadrupled, according to the Centers for Disease Control and Prevention. More than 90 people per day died in 2015 from an overdose of a prescription opioid or heroin – an illegal opioid made from morphine.

As the opioid epidemic continues, health care providers are hoping to do their part. For decades, the emphasis nationwide for treating surgical patients was to prescribe enough opioid pain medication to ensure they didn’t have any pain. But health care providers are realizing it’s a balancing act between managing pain and ensuring patients aren’t overprescribed.

To that end, Mayo Clinic researchers are studying the clinic’s opioid prescribing practices after surgery, outlining areas for improvement based on evidence, and implementing change. The team includes scientists in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, along with surgeons, pain medicine specialists, nurses and pharmacists. Their goal is to identify the right amount for each patient.

“The key factor is that we want to make a reduction in opioid prescriptions in an informed way – based on current patient needs – so that we don’t under-treat patients’ pain,” says Tad Mabry, M.D., a Mayo Clinic orthopedic surgeon. “We want to achieve the best possible patient outcomes, and patient experience, with minimal exposure to opioids.”

The research team published a study July 13 in the Annals of Surgery which highlighted prescribing practices from January 2013 to December 2015 for 25 common surgeries at Mayo Clinic campuses in Arizona, Florida and Rochester. In particular, the researchers examined patients who weren’t taking opioids in the 90 days before surgery. Within that group of 5,756 patients, they found 4 of 5 patients received more than recommended by Minnesota state guidelines now in development.

The median opioid prescription for that subgroup was equal to 50 pills of five-milligram oxycodone. That’s almost twice the amount the draft guidelines from the state of Minnesota recommend for a maximum, which is roughly a seven-day supply or about 27 pills of five-milligram oxycodone.

And, within that group, the prescriptions varied within specific surgical procedures and among the three campuses after adjusting for other factors. The Rochester campus median equaled 40 pills of oxycodone; whereas, the Arizona and Florida campuses’ median equaled 50 and 60 pills, respectively.

Based on these data, the Mayo Clinic Department of Orthopedic Surgery already has transformed its prescribing practices for patients who weren’t taking opioids in the 90 days before surgery. The department is developing four recommended levels based on surgical procedure and patient need.

“Furthermore, we have encouraged all our providers to maximize non-opioid pain strategies, such as ice, compression and over-the-counter medications,” Dr. Mabry says.

Next steps

Other departments – such as Neurosurgery, General Surgery and Obstetrics and Gynecology – are following suit with their own guidelines. And the Mayo Enterprise Opioid Stewardship Program Oversight Group is using this research to make institution-wide improvements.

While the researchers say this is just the first step, it’s advancing the practice in the right direction for the benefit of Mayo patients and the community.

“By publishing our experience we hope other institutions across the country begin a process similar to Mayo’s,” says co-author Robert Cima, M.D., a colorectal surgeon and medical director of surgical outcomes research.

It also provides a foundation for evidence-based guidelines for prescribing opioids post-surgery, something that was previously lacking.

“When I first looked at the medical literature I was surprised that, even for common surgeries, there wasn’t data to help guide surgeons on post-operative opioid prescribing practices,” says lead author Cornelius Thiels, D.O., a general surgery resident in the Mayo Clinic School of Graduate Medical Education, and alumnus of the Surgical Outcomes Research Fellowship.

The team also is hoping the study will help shape government policy and health care guidelines. The state of Minnesota is considering the study as it finalizes its guidelines, which in their current form aren’t appropriate for all cases, the researchers say.

“For some of the procedures, the guideline is probably appropriate and we have an opportunity to reduce the amount prescribed,” says senior author Elizabeth Habermann, Ph.D., scientific director of surgical outcomes research in the Kern Center for the Science of Health Care Delivery. “For some of the more painful procedures, in orthopedics, for example, the draft guideline is likely too low.”

Now, the team is surveying patients after surgery to see which types of patients are receiving excess opioids, and to determine how well they’re managing their pain.

“That’s important because pain is a very subjective experience and health care providers have to make sure they take the patients perspective into account when they alter how they treat their pain after surgery,” Dr. Thiels says.

The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery funded the research. The center analyzes data with the goal of making broad-based quality and efficiency improvements in patient care at Mayo and beyond.

The other authors ─ all from Mayo Clinic ─ are:

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Wed, Aug 2 8:19am · Mayo researchers to explore safety of combining blood-thinners

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Millions of Americans are taking blood-thinning drugs for common medical conditions. Often, they receive prescriptions for more than one when they have multiple chronic diseases or conditions. As Americans age and the number of people on these drugs is expected to steadily increase over the coming decades, researchers are trying to better understand how the drugs interact with each other.

With an RO1 grant from the Agency for Healthcare Research and Quality, Mayo Clinic researchers are doing exactly that.

Researchers in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery in Arizona will use the grant to explore bleeding risks within certain groups of patients and with specific drug combinations. The grant is for four years, beginning this month, and $1.58 million total.

Blood-thinning drugs are generally either anticoagulants, which lengthen the time it takes to form a blood clot, or antiplatelet drugs, which prevent blood cells called platelets from collecting to form clots. Anticoagulants are often used for atrial fibrillation, an irregular and often rapid heart rate, and venous thromboembolism, a blood clot in a vein – usually in the legs. Antiplatelets are used for conditions such as acute coronary syndrome, which causes decreased blood flow from the heart.

Anticoagulants include apixaban, dabigatran, edoxaban, rivaroxaban and warfarin. Examples of antiplatelets are aspirin, clopidogrel, dipyridamole, prasugrel and ticlopidine. Each of these blood-thinning drugs can cause gastrointestinal bleeding on their own, so researchers say it’s important to know more about what they do when used together.

mss_0001323549[1]“Knowing the real-world bleeding risks of these blood-thinners and which patients are most at risk will help health care providers and their patients make informed decisions,” says the grant’s principal investigator, Neena S. Abraham, M.D., a gastroenterologist and health sciences researcher at Mayo Clinic.

The researchers plan to fill this knowledge gap by showing what percentage of patients are at risk for gastrointestinal bleeding based on the presence of individual and combinations of certain factors. Those factors include age, patients with multiple conditions, liver failure and renal failure. The study will also look at the risk of bleeding when blood-thinners are used in combination for atrial fibrillation, acute coronary syndrome or venous thromboembolism.

“Using scientific data and machine learning techniques to predict risk factors and at at-risk groups is the first step in improving outcomes for patients,” Dr. Abraham says.

Dr. Abraham is site director in Arizona of the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. The center analyzes data with the goal of making broad-based quality and efficiency improvements in patient care at Mayo and beyond.

The center’s research team also has published related studies on the safety and effectiveness of blood-thinning drugs, comparing newer drugs’ risk of bleeding, and health care providers’ prescribing practices, among others.

Wed, Jun 28 8:03am · Underused cancer test could improve treatment for thousands, Mayo Clinic study finds

A simple blood test could improve treatment for 1 in 6 stage 2 colon cancer patients, new Mayo Clinic research finds.

Colorectal cancer is the fourth most common cancer in the U.S. and the second deadliest. With colon cancer, some earlier stage patients fare worse than some later stage patients, who usually benefit most from chemotherapy. But a research team at Mayo Clinic has discovered that a simple blood test could help determine which patients are at a higher risk and therefore could benefit from therapy.

The researchers also found many patients who could benefit from the test likely aren’t receiving it.

The team of physicians and scientists, using data from the National Cancer Database for 40,844 patients, looked at a blood test that measures the protein called carcinoembryonic antigen, or CEA. Carcinoembryonic antigen can be found in higher levels in people with certain cancers, especially colon cancer.

The findings, published in the Journal of Gastrointestinal Surgery, showed that knowing these blood test results prior to treatment could have changed the classification from average to high risk for more than 1 in 6 stage 2 colon cancer patients. That change could have altered treatment options, including whether to use chemotherapy.

“The decision to give a patient chemotherapy after surgery is not a light one, and physicians must weigh the risks and benefits,” says senior author Kellie Mathis, M.D., a Mayo Clinic colon and rectal surgeon. “We are currently using the blood test to help make these difficult decisions, and we suggest other physicians do the same.”

The blood test has been around for decades but is not broadly used across the country. It was recorded in 54 percent of cases meeting other relevant criteria for the study. While in some cases the test may not have been entered in the database, many other patients may not be getting it.

“There is no good reason for a physician to omit this blood test, and more work needs to be done to ensure that all patients receive it,” Dr. Mathis says.

When patients get the blood test, the authors point out it is often done after surgery to monitor the cancer’s development. Greater, and earlier, consideration of protein level may be warranted, the researchers say.

The researchers also discovered that, for stage 2 patients who had surgery but not chemotherapy, the five-year survival rate was 66 percent for those with elevated protein levels and 76 percent for those without elevated levels. And for patients with elevated protein levels, those who had chemotherapy and surgery fared better than those who only had surgery.

“If a patient with a new diagnosis of stage 2 colon cancer has an elevated carcinoembryonic antigen level, physicians should consider chemotherapy in addition to surgery,” says Dr. Mathis.

There are four primary stages of colon cancer. Generally, with stage 2, the cancer hasn’t spread to nearby lymph nodes or distant organs but has grown into or through the wall of the colon.

To perform the patient-centered research, physicians in the Mayo Clinic Division of Colon and Rectal Surgery collaborated with scientists in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

The lead author is Blake Spindler, M.D., a resident in the Mayo Clinic School of Graduate Medical Education. The other authors are John Bergquist, M.D., and Cornelius Thiels, D.O., both residents in the Mayo Clinic School of Graduate Medical Education, and Elizabeth Habermann, Ph.D., Scott Kelley, M.D., and David W. Larson, M.D., all from Mayo Clinic.

The study was funded by the Mayo Clinic Department of Surgery, the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and the Mayo Clinic Clinician-Investigator Training Program.

Mon, Jun 19 7:56am · 1 in 6 taking blood-thinning drugs may not be getting right dose, research shows

Dr. Peter Noseworthy is a Mayo Clinic cardiologist and a senior author of the research. He is also a former Kern Health Care Delivery Scholar in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

Over the coming decades, a growing number of Americans are expected to develop atrial fibrillation, a common heart condition characterized by an irregular and often rapid heart rate. The Centers for Disease Control and Prevention estimates that between 2.7 and 6.1 million Americans are living with the condition, which is also associated with a fivefold greater risk of stroke.

But almost 1 in 6 of the millions of Americans on new blood-thinning medications for atrial fibrillation may not be receiving the recommended dose, Mayo Clinic research finds.

Roughly 10 percent of patients on these drugs have severe kidney disease, and the research, published June 5 in the Journal of the American College of Cardiology, found that more than 40 percent of them are receiving a higher dose than recommended. That could lead to serious bleeding risks.

Also, among the 90 percent of patients without severe kidney disease, 13 percent may be underdosed. The researchers found that for one medication in the group – apixaban – underdosing may be less effective at preventing strokes.

Xiaoxi Yao, Ph.D.

“Dosing errors of these blood-thinning medications in patients with atrial fibrillation are common and have concerning adverse outcomes,” says Xiaoxi Yao, Ph.D., a health sciences researcher at Mayo Clinic and the paper’s lead author.

The paper looked at 14,865 patients from October 2010 to September 2015 on the blood-thinning drugs apixaban, dabigatran or rivaroxaban for atrial fibrillation. All three medications have a standard dose for most patients and a lower dose for patients with kidney issues. Blood-thinners are recommended for up to 90 percent of patients with atrial fibrillation as lifelong therapy.

“The number of patients using these drugs has quickly increased since the introduction of this new class of drugs in 2010,” says Dr. Yao. Before that, the standard blood-thinning drug since the 1950s was warfarin, which requires constant monitoring and doctor visits.

Using the OptumLabs Data Warehouse, a database of de-identified, linked clinical and administrative claims information, the study found that 16 percent of the patients received a dose inconsistent with U.S. Food and Drug Administration labeling. Among the patients with severe kidney impairment, 43 percent received the standard dose ─ a potential overdose. Overdosing was associated with a higher risk of major bleeding but no significant difference in stroke prevention.

Among patients without severe kidney disease, 13 percent got the lower dose ─ a potential underdose. The lower dose was associated with a higher risk of stroke but no difference for bleeding risks for apixaban users. There wasn’t a significant relationship between underdosing and the risks of stroke or bleeding for dabigatran or rivaroxaban users.

Peter Noseworthy, M.D.

“We conducted this study to highlight the prevalence of inappropriate dosing in routine clinical practice and the associated adverse outcomes,” says Peter Noseworthy, M.D., a Mayo Clinic cardiologist and the paper’s senior author. “This study underscores the importance for physicians to be vigilant of kidney function when selecting or adjusting dose.”

Blood-thinning medication dosing is complex, and there are many factors health care providers consider when prescribing the drugs. They have to weigh the benefits and harms, and account for possible drug interactions, among other concerns.

The researchers also note that, because these blood-thinners are preventive, health care providers can’t be certain the medication prevented a stroke, but they can link bleeding events to the drugs. This could cause some providers to be cautious and prescribe a lower dose.

“Overdosing is a fairly straightforward problem and can be avoided by regularly monitoring kidney function,” says Dr. Noseworthy. “However, underdosing is more complex. These medications need to strike a balance between stroke reduction and risk of bleeding. I think physicians often choose to reduce the dose when they anticipate their patients are at a particularly high bleeding risk ─ independent of kidney function.”

For the patients’ part, they should ensure health care providers have updated medical history information and a current list of medications, especially if they see multiple providers at different hospitals or clinics.

“Physicians will also need to regularly follow up with patients on these medications to detect change in kidney function and adapt the dose accordingly,” says Dr. Yao.

The findings are a collaboration between Mayo Clinic physicians and researchers in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. The teamwork ensures the research questions address unmet patient needs and places the findings in a perspective that can improve clinical practice.

Additional research team members ─ all from Mayo Clinic ─ are:

A version of this post originally appeared on the Mayo Clinic News Network

Wed, May 10 8:04am · Research looks to improve patient satisfaction, reduce costs by predicting surgery length

Accurately predicting the length of an operation has benefits beyond simply informing patients and their families. Doing so means improved patient satisfaction and has the potential to prevent over- or under-utilization of operating rooms, which has significant implications on both resources and staff. Ultimately, that leads to improved quality of care for patients, improved well-being for surgical teams, and reduced costs for hospitals.

With that in mind, Mayo Clinic researchers have shown that by looking at patients’ specific traits they can more accurately predict the length of an operation.

“From an efficiency stand-point the current systems are often unreliable and contribute to costly overestimation and underestimation of surgery length,” says Cornelius Thiels, D.O., M.B.A., a Mayo Clinic resident and a lead author for the research.

Making the most of available resources means more patients can get the care they need more efficiently and with less overtime for hospitals.

“Patients do not want to wait weeks to have their surgery due to a backlog, but patients also do not want to wait all day for their surgery to start due to poorly planned operating room schedules,” says Dr. Thiels, who did the research as a fellow in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

The research team published a pair of papers to show which factors can help predict surgery length. The team found male gender, obesity, younger age, abnormal liver function, and patients with other significant health problems are all possible predictors of longer surgeries for a common procedure: minimally invasive gallbladder removal. The model they used predicted the operation length more accurately, and it also better identified groups of patients who are more likely to have extremely short or long operations.

“Predicting these outliers is equally important, as outliers are the most costly to the system,” the researchers wrote. “Even small gains can have significant impact.”

The first paper, published recently in The American Journal of Surgery, used 24,099 cases in the American College of Surgeons National Surgical Quality Improvement Program database. The paper looked at patients who underwent minimally invasive gallbladder removal surgery to find which factors can help predict operative duration, and which aren’t as useful, including smoking, cardiovascular disease, chronic obstructive pulmonary disease (COPD), diabetes, and an abnormal white blood cell count. The second paper, published recently in the journal Surgical Endoscopy, confirmed the findings using 1,801 cases at Mayo Clinic from 2007 through June 2013, and 11,842 cases between 2005 and 2013 from the database. That paper also determined the time impact for each useful patient factor.

“Using the American College of Surgeons National Surgical Quality Improvement Program database, we were able to broaden our patient sample and strengthen our prediction model beyond what would be possible when limited to our internal data,” says Bethany Lowndes, Ph.D., a health sciences researcher in the Center for the Science of Health Care Delivery and a lead author for the research.

The research was done in collaboration between the Mayo Clinic Division of Subspecialty General Surgery, and the Surgical Outcomes and Health Care Systems Engineering programs in the Center for the Science of Health Care Delivery.

“This type of cross-divisional research has the greatest potential to be not only scientifically fruitful but also is more likely to result in translational research,” says Dr. Thiels.

An aging U.S. population and an increasing percentage of obese patients also complicate scheduling predictions, and make a model that accounts for those factors more useful.

Current scheduling systems are fairly inaccurate, and typically predict the average operation length, but don’t account for significantly longer or shorter cases, the researchers wrote. Other studies have looked at patient factors related to operative duration, but they haven’t been translated into a model that can be used in practice yet.

This research began with that in mind, and because it was initiated by clinicians looking to solve that problem, it should help with execution.

“When the research is complete, the desire to implement it into practice has already been fostered,” says Dr. Lowndes.

To improve their model’s accuracy, researchers suggest using other potential factors for this operation – which weren’t available in the database – including the presence of gallstones or previous abdominal scarring, surgery or tenderness.  Researchers also will need to test and validate the model for other procedures.

“This will allow us to apply it to various surgical procedures and improve predictability,” says Dr. Lowndes.

At that point, the researchers hope it can be implemented into the surgical scheduling process and improve access for patients.

“Given that every hospital could benefit financially from improved operative time prediction, we feel this first step is important,” the researchers wrote.

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