Diagnosed with prostate cancer at age 60, Hart had undergone virtually every treatment 鈥� surgery, radiation and hormones 鈥� to eradicate it. But a blood test showed that his level of prostate-specific antigen, which should have been undetectable, kept rising ominously. And doctors couldn’t determine where the residual cancer was lurking.

“I didn’t like the sound of that,” said Hart, a retired international oil specialist for the federal government. “I wanted it gone,” he added, especially after learning that he had inherited the , making him vulnerable to other cancers.

So when Andrew Joel, Hart’s longtime urologist at in Arlington, mentioned the hospital’s membership in the and suggested consulting specialists at the Rochester, Minn., hospital for a second opinion, Hart enthusiastically agreed.

A Mayo immunologist told Joel about a , not then available in the Washington area, that can detect tiny cancer hot spots. Hart flew to Mayo for the scan, which found cancer cells in one lymph node in his pelvis. He underwent chemotherapy at Virginia Hospital Center and five weeks of radiation at the Mayo Clinic. Since September 2016, there has been no detectable cancer.

“This collaboration was sort of a magic process,” Hart said. “I feel very fortunate.”

‘Benefit By Association’

Hart’s experience showcases the promise of a much-touted but little understood collaboration in health care: alliances between community hospitals and some of the nation’s biggest and most respected institutions.

For prospective patients, it can be hard to assess what these relationships actually mean 鈥� and whether they matter.

Leah Binder, president and chief executive of , a Washington-based patient safety organization that grades hospitals based on data involving medical errors and best practices, cautions that affiliation with a famous name is not a guarantee of quality.

“Brand names don’t always signify the highest quality of care,” she said. “And hospitals are really complicated places.”

Affiliation agreements are “essentially benefit by association,” said Gerard Anderson, a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. “In some cases it’s purely branding and in other cases it’s a deep association.”

A key question is “how often does the community hospital interact with the flagship hospital? If it’s once a week, that’s one thing. If it’s almost never, that’s another,” Anderson said.

Feeling ‘Plugged In’

To expand their reach, flagship hospitals including Mayo, and Houston’s have signed affiliation agreements with smaller hospitals around the country. These agreements, which can involve different levels of clinical integration, typically grant community hospitals access to experts and specialized services at the larger hospitals while allowing them to remain independently owned and operated. For community hospitals, a primary goal of the brand-name affiliation is stemming the loss of patients to local competitors.

In return, large hospitals receive new sources of patients for clinical trials and for the highly specialized services that distinguish these “destination medicine” sites. Affiliations also boost their name recognition 鈥� all without having to establish a physical presence.

In some cases, large hospital systems opt for a different approach, largely involving acquisition. Johns Hopkins and Suburban hospitals in the Washington, D.C., area, along with All Children’s Hospital in St. Petersburg, Fla. The latter was re-christened Johns Hopkins All Children’s Hospital in 2016.

New York’s Memorial Sloan Kettering Cancer Center has embraced a hybrid strategy. It operates a surrounding Manhattan and has with three partners in Connecticut, Pennsylvania and Florida.

“Every one of these models is different,” said Ben Umansky, managing director for research at the Advisory Board, a Washington-based consulting firm.

Local hospitals, he said, particularly those operating “in the shadows of giants,” may be better able to retain patients “by getting a name brand on their door. … There is a sense that they are plugged in.” (Virginia Hospital Center, for example, competes with Hopkins, MedStar Washington Hospital Center, which has an alliance with the Cleveland Clinic, and the Northern Virginia-based Inova system.)

Doctors can obtain speedy second opinions for their patients and streamline visits for those with complex or unusual medical needs, processes that can be daunting and difficult without connections.

Dr. Michael Kupferman, senior vice president of the MD Anderson Cancer Network, said it seeks to “elevate the quality of cancer care” by forming partnerships with “high-quality [hospitals] to keep patients at home and provide the imprimatur of MD Anderson.”

Virginia Hospital Center’s association with Mayo is “not just a branding affiliation, it’s a deep clinical affiliation,” said Dr. Jeffrey DiLisi, senior vice president and chief medical officer at the Arlington facility.

Despite extensive marketing, many patients seem unaware of the linkage. “We still think a lot about ‘How do we communicate this?'” DiLisi said.

Although affiliation agreements differ, many involve payment of an annual fee by smaller hospitals. Officials at Mayo and MD Anderson declined to reveal the amount, as did executives at several affiliates. Contracts with Mayo must be renewed annually, while some with MD Anderson exceed five years.

Acceptance is preceded by site visits and vetting of the community hospitals’ staff and operations. Strict guidelines control use of the flagship name.

“It is not the Mayo Clinic,” said Dr. David Hayes, medical director of the Mayo Clinic Care Network, which was launched in 2011. “It is a Mayo clinic affiliate.”

Of the 250 U.S. hospitals or health systems that have expressed serious interest in joining Mayo’s network, 34 have become members.

For patients considering a hospital that has such an affiliation, Binder advises checking ratings from a variety of sources, among them Leapfrog, and , and not just relying on reputation.

“In theory, it can be very helpful,” Binder said of such alliances. “The problem is that theory and reality don’t always come together in health care.”

Case in point: Hopkins’ All Children’s has been聽 of catastrophic surgical injuries and errors and a spike in deaths among pediatric heart patients since Hopkins took over. Hopkins’ chief executive has apologized, more than a half-dozen and Hopkins recently to conduct a review of what went wrong.

“For me and my family, I always look at the data,” Binder said. “Nothing else matters if you’re not taken care of in a hospital, or you have the best surgeon in the world and die from an infection.”

Cancer During Pregnancy

Bryan Mills, chief executive of , was unhappy with his oncology service. Specialists at the Indianapolis-area hospitals he headed were competing against each other and patients were being ill-served. So Mills cold-called MD Anderson and, in 2012, Community joined its network.

“We needed something we could rally around,” Mills said.

“This is really not about a competitive advantage to me, but about providing optimal care,” said Mills, whose network competes with three other systems including one run by the University of Indiana, which operates a .

“One hundred percent of the work we do is audited by MD Anderson,” Mills said. “We can get second opinions almost instantly.”

Mills said he believes that the affiliation, which is prominently displayed on Community’s website, has attracted patients. In 2012, he said, Community treated about 2,000 cancer patients. In 2018, the number was 5,000.

Among them is Kamaljit “Kelly” Kaur. Shortly before Christmas 2015 the Greenwood, Ind., licensed practical nurse was diagnosed with , a rare and aggressive form of the disease usually discovered at an advanced stage. At the time, Kaur was 35 and five months pregnant with her third child.

Kaur said that her Indiana doctors conferred with MD Anderson oncologists and used “their guidelines to treat me. I felt comforted by that, like it was the right choice for me.” Her biggest concern, she said, was the health of her baby.

During the final months of her pregnancy, Kaur received weekly chemotherapy. Her son was born healthy and at full term in February 2016. She then underwent a bilateral mastectomy, followed by more chemo and radiation. Kaur said she has been cancer-free since January 2017, when she finished treatment. The collaboration, she said, “helped me get through this.”

Kaur’s Indiana oncologist, Dr. Anuj Agarwala, said he thought the MD Anderson involvement was helpful, because it reassured Kaur and him by concurring with his recommendations. He said he presented his treatment plan to specialists in Houston and “they didn’t change anything.”

Overall, he said, “it really doesn’t affect what I do very much. We are following national guidelines and not giving off-the-wall treatment.”

Initially, Agarwala said, some Community oncologists bristled at having their charts audited by Houston specialists, a resistance he said has diminished.

The affiliation has strengthened safety measures involving the administration of chemotherapy and has made the informed consent process more rigorous, Agarwala said, to the benefit of patients. “Overall it has been a valuable relationship.”

“The population I work with don’t have the resources to get care outside of their hometown,” he added, “and feel more confident with the input of a world-class institution.”

So did Dr. James Ouellette, a cancer surgeon with Premier Health in Dayton, Ohio, which joined the MD Anderson network in 2016.

In November 2018, Ouellette removed a huge and rare malignant tumor from Joanne Dotson’s abdomen during a four-hour surgery. The solitary fibrous tumor was in a dicey location: It had grown so large it was displacing Dotson’s liver and compressing her vena cava, a major vein that carries blood to the heart.

Dotson, 70, said she had never heard of MD Anderson until her doctors mentioned it.

The affiliation, she said, did not affect her choice of hospital or surgeon, in whom she had confidence.

“I wasn’t even worried,” she said. “His hands are God’s hands,” she said, referring to Ouellette.

Her surgeon felt differently.

“While I was very glad Mrs. Dotson wasn’t worried, I was, with a big surgery like that,” Ouellette said. Before the operation, Ouellette said he conferred with an MD Anderson surgeon, radiation oncologist and medical oncologist about how best to treat the grapefruit-size growth. As a result of those discussions, Ouellette said, he altered the initial treatment plan.

Getting A Vibe

Virginia Hospital Center officials say that only a handful of the approximately 170 patients, the vast majority with cancer diagnoses, who annually receive second opinions from Mayo wind up getting treatment there. Most of those who do, DiLisi said, received care unavailable at his hospital.

“The patients [that affiliates] send us are more complex patients,” said Mayo’s Hayes. “We have a broad and deep bench of specialists.”

Even so, it’s often doctors who suggest a second opinion, not patients who request one. Joel said he mentions the option to those urology patients from whom he gets “a vibe” that they might be interested.

DiLisi said that the affiliation can save patients time and money.

“We get them as good a second opinion as they would get at Hopkins,” DiLisi said, without incurring the costs and additional testing involved. “And they don’t have to drive to Baltimore.”

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Since his graduation last year from the University of San Diego, Brown has held a series of jobs that have taken him to several California cities. “As a young person in a nomadic state,” Brown said, he prefers finding a walk-in clinic on the rare occasions when he’s sick.

“The whole ‘going to the doctor’ phenomenon is something that’s fading away from our generation,” said Brown, who now lives in Daly City outside San Francisco. “It means getting in a car [and] going to a waiting room.” In his view, urgent care, which costs him about $40 per visit, is more convenient聽鈥� “like speed dating. Services are rendered in a quick manner.”

Brown’s views appear to be shared by many millennials, the 83 million Americans born between 1981 and 1996 who constitute the nation’s biggest generation. Their preferences 鈥� for convenience, fast service, connectivity and price transparency 鈥� are upending the time-honored model of office-based primary care.

Many young adults are turning to a fast-growing constellation of alternatives: retail clinics carved out of drugstores or big-box retail outlets, free-standing urgent care centers that tout evening and weekend hours, and online telemedicine sites that offer virtual visits without having to leave home. Unlike doctors’ offices, where charges are often opaque and disclosed only after services are rendered, many clinics and telemedicine sites post their prices.

A of 1,200 randomly selected adults conducted in July by the Kaiser Family Foundation for this story found that 26 percent said they did not have a primary care provider. There was a pronounced difference among age groups: 45 percent of 18- to 29-year-olds had no primary care provider, compared with 28 percent of those 30 to 49, 18 percent of those 50 to 64 and 12 percent age 65 and older. (Kaiser Health News is an editorially independent program of the foundation.)

A by the Employee Benefit Research Institute, a Washington think tank, and Greenwald and Associates yielded similar results: 33 percent of millennials did not have a regular doctor, compared with 15 percent of those age 50 to 64.

“There is a generational shift,” said Dr.聽, an internist and associate professor in the Department of Health Care Policy at Harvard Medical School. “These trends are more evident among millennials, but not unique to them. I think people’s expectations have changed. Convenience [is prized] in almost every aspect of our lives,” from shopping to online banking.

So is speed. Younger patients, Mehrotra noted, are unwilling to wait a few days to see a doctor for an acute problem, a situation that used to be routine. “Now,” Mehrotra said, “people say, ‘That’s crazy, why would I wait that long?'”

Until recently, the after-hours alternative to a doctor’s office for treatment of a strep throat or other acute problem was a hospital emergency room, which usually meant a long wait and a big bill.

Luring Millennials

For decades, primary care physicians have been the doctors with whom patients had the closest relationship, a bond that can last years. An internist, family physician, geriatrician or general practitioner traditionally served as a trusted adviser who coordinated care, ordered tests, helped sort out treatment options and made referrals to specialists.

But some experts warn that moving away from a one-on-one relationship may be and worsening the problem of fragmented or unnecessary care, including the misuse of antibiotics.

A recent report in JAMA Internal Medicine found that nearly half of patients who sought treatment at an urgent care clinic for a cold, the flu or a similar respiratory ailment left with an unnecessary and potentially harmful prescription for antibiotics, compared with 17 percent of those seen in a doctor’s office. Antibiotics are useless against viruses and may expose patients to severe side effects with just a single dose.

“I’ve seen many people who go to five different places to be treated for a UTI [urinary tract infection] who don’t have a UTI,” said Dr. Janis Orlowski, a nephrologist who is chief health care officer at the Association of American Medical Colleges, or AAMC. “That’s where I see the problem of not having some kind of continuous care.”

“We all need care that is coordinated and longitudinal,” said Dr. Michael Munger, president of the American Academy of Family Physicians, who practices in Overland Park, Kan. “Regardless of how healthy you are, you need someone who knows you.” The best time to find that person, Munger and others say, is before a health crisis, not during one.

And that may mean waiting weeks. A by physician search firm Merritt Hawkins found that the average wait time for a new-patient appointment with a primary care doctor in 15 large metropolitan areas is 24 days, up from 18.5 days in 2014.

While wait times for new patients may reflect a聽 鈥� in the view of the AAMC 鈥� or a , as other experts argue, there is no dispute that primary care alternatives have exploded. There are now more than in the United States, most in the South and Midwest, according to Rand Corp. researchers.

Connecting With Care

To attract and retain patients, especially young adults, primary care practices are embracing new ways of doing business.

Many are hiring additional physicians and nurse practitioners to see patients more quickly. They have rolled out patient portals and other digital tools that enable people to communicate with their doctors and make appointments via their smartphones. Some are exploring the use of video visits.

Mott Blair, a family physician in Wallace, N.C., a rural community 35 miles north of Wilmington, said he and his partners have made changes to accommodate millennials, who make up a third of their practice.

“We do far more messaging and interaction through electronic interface,” he said. “I think millennials expect that kind of connectivity.” Blair said his practice has also added same-day appointments.

Although walk-in clinics may be fine as an option for some illnesses, few are equipped to provide holistic care, offer knowledgeable referrals to specialists or help patients decide whether they really need, say, knee surgery, he noted. Primary care doctors “treat the whole patient. We’re tracking things like: Did you get your mammogram? Flu shot? Pap smear? Eye exam?”

Dr. Nitin Damle, an internist and past president of the American College of Physicians, said that young people develop diabetes, hypertension and other problems “that require more than one visit.”

“We know who the best and most appropriate specialists in the area are,” said Damle, an associate clinical professor of medicine at Brown University in Providence, R.I. “We know who to go to for asthma, allergies, inflammatory bowel disease.”

Marquenttha Purvis, 38, said her primary care doctor was instrumental in helping arrange treatment for her stage 2 breast cancer last year. “It was important because I wouldn’t have been able to get the care I needed” without him, said Purvis, who lives in Richmond, Va.

Sometimes the fragmented care that can result from not having a doctor has serious consequences.

Orlowski cites the case of a relative, a 40-year-old corporate executive with excellent medical insurance. The man had always been healthy and didn’t think he needed a primary care physician.

“Between treating himself and then going to outpatient clinics,” he spent nearly a year battling a sore throat that turned out to be advanced throat cancer, she said.

For patients without symptoms or a chronic condition such as asthma or high blood pressure, a yearly visit to a primary care doctor may not be necessary. Experts no longer recommend the for people of all ages.

“Not all access has to be with you sitting on an exam table,” Munger said. “And I may not need to see you more than every three years. But I should be that first point of contact.”

Convenience Is Paramount

Caitlin Jozefcyk, 30, a high school history teacher in Sparta, N.J., uses urgent care when she’s sick. She dumped her primary care doctor seven years ago because “getting an appointment was so difficult” and he routinely ran 45 minutes behind schedule. During her recent pregnancy, she saw her obstetrician.

Jozefcyk knows she’s not building a relationship with a physician 鈥� she sees different doctors at the center聽鈥� but “really likes the convenience” and extended hours.

Digital access is also important to her. “I can make appointments directly through an app, and prescriptions are sent directly to the pharmacy,” she said.

After years of going to an urgent care center or, when necessary, an emergency room, Jessica Luoma, a 29-year-old stay-at-home mother in San Francisco, recently decided to find a primary care doctor.

“I’m very healthy, very active,” said Luoma, who has been treated for a kidney infection and a miscarriage.

Luoma said her husband pushed her to find a doctor after the insurance offered by his new employer kicked in.

“He’s a little more ‘safety first’ than me,” she said. “I figured, ‘Why not?’ 鈥� just in case.”

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Devitt’s white blood cell count and several other tests were flagged as abnormal. Beyond the raw numbers, there was no explanation.

“I got really tense and concerned,” said Devitt, 39, a manager of data analysis who lives in New Orleans. She immediately began searching online and discovered that possible causes ranged from a trivial infection to cancer.

“I was able to calm myself down,” said Devitt, who waited anxiously for her doctor to call. Two days later, after hearing nothing, she called the office. Her doctor telephoned the next day. She reassured Devitt that the probable cause was her 5-year-old’s recent case of pinkeye and advised her to get tested again. She did, and the results were normal.

“I think getting [test results] online is great,” said Devitt, who says she wishes she had been spared days of needless worry waiting for her doctor’s explanation. “But if it’s concerning, there should be some sort of note from a doctor.”

Devitt’s experience illustrates both the promise and the perils of a largely unexamined transformation in the way growing numbers of Americans receive sensitive 鈥� sometimes life-changing 鈥� medical information. A decade ago, most patients were informed over the phone or in person by the doctor who had ordered testing and could explain the results.

But in the past few years, hospitals and medical practices have urged patients to sign up for portals, which allow them rapid, round-the-clock access to their records. Lab tests (with few exceptions) are now released directly to patients. Studies estimate that between 15 and 30 percent of patients use portals.

The push for portals has been fueled by several factors: the widespread embrace of technology, incentive payments to medical practices and hospitals that were part of 2009 federal legislation to encourage “” of electronic records, and a giving patients direct access to their results. Policymakers have long regarded electronic medical records as a way to foster patient engagement and improve patient safety. Studies have found that of abnormal lab results were not communicated to patients promptly.

Are portals delivering on their promise to engage patients? Or are these results too often a source of confusion and alarm for patients and the cause of more work for doctors because information is provided without adequate 鈥� or sometimes any 鈥� guidance?

Releasing results on portals remains “an answer with many questions,” said Hardeep Singh, a patient safety researcher at the Michael E. DeBakey VA Medical Center in Houston. “There is just not enough information about how it should be done right,” said Singh, who is also an associate professor at Baylor College of Medicine and one of the few researchers to study patients’ experiences obtaining test results from portals. “There are unintended consequences for not thinking it through.”

Although what patients see online and how quickly they see it differs 鈥� sometimes even within the same hospital system 鈥� most portals contain lab tests, imaging studies, pathology reports and less frequently, doctors’ notes. It is not uncommon for a test result to be posted before the doctor has seen it.

That means that a patient may be the first to learn of a suspicious breast mass, a recurrence of cancer or possible kidney failure. At Johns Hopkins medical system in Baltimore, for example, results of a PSA test to screen for prostate cancer come with this disclaimer: “While Johns Hopkins providers check results frequently, you may see results before your provider has seen them.”

Breast cancer specialist Lidia Schapira is an associate professor at the Stanford University Medical Center and editor-in-chief of Cancer.net, the patient information website of the American Society of Clinical Oncology. While she regards online access as beneficial, “the danger is that the patient may learn information they’re unprepared to receive and may feel abandoned if they can’t reach their doctor.”

“Those are the Friday afternoon phone calls,” she said, when “at 4:59 [p.m.] a patient has accessed the results of a scan and the doctor signs out at 5.” The recipient of the anguished inquiry that follows is typically a covering doctor who doesn’t know the patient or details of the case.

When Is Use Meaningful?

A by Singh and his colleagues found that, like Devitt, nearly two-thirds of 95 patients who obtained test results via a portal received no explanatory information about the findings. As a result, nearly half conducted online searches. Many with abnormal results called their doctors.

That echoes a led by researchers from the University of Pittsburgh. These scientists found that in addition to engaging patients, portal use may increase anxiety and lead to more doctor visits.

Among patients with low health literacy and numerical skills, confusion about the meaning of results is common. Many tests are reported in the same form that the doctor sees them, which even savvy patients may find “literally meaningless,” observed Brian Zikmund-Fisher, an associate professor in the school of public health at the University of Michigan.

“In some situations we run the risk of patients misinterpreting that there is no problem when there is one, or assuming there’s a problem when there isn’t,” said Zikmund-Fisher, lead author of a study that advocates the use of to convey results. “What we need to be focusing on is giving patients context.”

A year or so ago, Geisinger Health System in Pennsylvania began making most test results 鈥� but not biopsies or HIV screening 鈥� available to patients within four hours of being finalized.

“We essentially release results twice a day seven days a week with a four-hour lag,” said Ben Hohmuth, Geisinger’s associate chief medical informatics officer. The delay, he said, gives doctors time to review results. Patients who log on over a weekend can contact an on-call physician if they can’t reach their own doctor. The goal of rapid release, Hohmuth said, is to “be patient-centered and transparent.”

“The majority [of patients] want early access to their results, and they don’t want it to be impeded” while waiting for doctors to contact them, Hohmuth said, even if the news is bad.

Patient reaction, he adds, has been “overwhelmingly positive”; the few complaints have come from physicians.

Health lawyer Kathleen Kenyon said she would have appreciated faster access to blood test results for her elderly mother, who had multiple medical problems including Alzheimer’s disease. Kenyon, who managed and closely monitored her mother’s condition, said she believes speedier access could have helped stave off a four-day hospitalization in the intensive care unit of a Washington hospital caused by her mother’s plummeting sodium level.

“It is safer for patients to have more information,” said Kenyon, formerly a senior policy analyst at the Department of Health and Human Services. “I was begging them to get my mother’s lab information in earlier.”

What Does This Mean?

At 46, writer Rebecca Esparza has survived Stage 4 ovarian cancer as well as thyroid cancer. She normally loves having round-the-clock access to her records and the ability to email her doctors.

But in 2016, immediately after extensive abdominal surgery at a hospital several hours from her home in Corpus Christi, Texas, doctors told her they suspected she had developed colon cancer. Confirmation would require further evaluation by a pathologist.

Esparza went home and waited, checking her portal repeatedly. A week later, she logged on to find a highly technical biopsy report she could not understand. A friend who is a nurse read it and told Esparza there was no mention of a malignancy. Two weeks after Esparaza left the hospital and a week after the report appeared on her portal, one of her doctors confirmed that she didn’t have cancer after all.

“It was really traumatic and the one time I wish I hadn’t had access,” said Esparza, an advocate for the National Coalition for Cancer Survivorship.

Although Esparza considers her experience to be “a fluke,” she notes similar confusion among other cancer patients in the online support groups she runs.

“People post their blood test and other results all the time and ask what it means,” she said. Esparza said she intercedes by reminding participants “we’re not doctors.”

One way for a physician to provide guidance, said Stanford’s Schapira, is for doctors to negotiate with patients in advance, particularly if they are concerned the news might be bad.

It is a strategy she employed at her previous job at Massachusetts General Hospital in Boston. “I would say, ‘Let’s do a scan and then schedule a visit two days later, and we can discuss the results,'” she said.

One Doctor’s Experience

Mass General internist Katharine Treadway knows what it’s like to obtain shocking news from an electronic medical record. The experience, she said, has influenced the way she practices.

More than a decade ago 鈥� long before most patients had portals 鈥� Treadway, with her husband’s permission, pulled up the results of his MRI scan on a hospital computer while waiting to see the specialist treating his sudden, searing arm pain.

“It showed a massive tumor” and widespread metastatic disease, Treadway recalled. She never suspected that her 59-year-old husband had cancer, let alone a highly aggressive and usually fatal form of advanced lymphoma.

Treadway said she remembers intently checking the name and date of birth, certain she had the wrong patient, then rebooting the computer several times “like I was going to get a different answer.”

“The difference is that I knew exactly who to call and what to do,” said Treadway, whose for more than a decade. “In the event of bad news, a doctor has to surround the patient with ‘I am here for you and here’s the plan.'”

Schapira agrees. “Clinicians have to start tackling the issues that have arisen as a result of instant access,” she said.

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For decades, experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons. Researchers 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions, a figure that jumps to nearly 46 percent for those between 70 and 79. Doctors say it is not uncommon to encounter patients taking more than 20 drugs to treat acid reflux, heart disease, depression or insomnia or other disorders.

Unlike the overuse of opioid painkillers, the polypharmacy problem has attracted little attention, even though its hazards are well documented. But some doctors are working to reverse the trend.

At least 15 percent of seniors seeking care annually from doctors or hospitals have suffered a medication problem; in half of these cases, the problem is believed to be potentially preventable. Studies have linked polypharmacy to . Older patients, who have greater difficulty metabolizing medicines, are more likely to suffer dizziness, confusion and falls. And the side effects of drugs are frequently misinterpreted as a new problem, triggering more prescriptions, a process known as a .

The glide path to overuse can be gradual: A patient taking a drug to lower blood pressure develops swollen ankles, so a doctor聽prescribes a diuretic. The diuretic causes a potassium deficiency, resulting in a medicine to treat low potassium. But that聽triggers nausea, which is treated with another drug, which causes confusion, which in turn is treated with more medication.

For many patients, problems arise when they are discharged from the hospital on a host of new medications, layered on top聽of old ones.

Alice Cave, who divides her time between Alexandria, Va., and Tucson, Ariz., discovered this when she traveled to Cheyenne, Wyo., after her 87-year-old aunt was sent home following treatment for a stroke in 2015.

Before her hospitalization, Cave said, her aunt, a retired telephone company employee whose vision is impaired by glaucoma, had been taking seven drugs per day. Five new ones were added in the hospital, Cave said.

“She came home and had a huge bag of pills, half of which she was already taking, plus pages and pages of instructions,” she聽said. Some were supposed to be taken with food, some on an empty stomach. Cave said she spent several hours sorting the medications聽into a giant blue pill box. “It was crazy — and scary.”

Cave said she felt helpless to do much; her aunt’s doctors didn’t question the need for more drugs.

When Shannon Brownlee’s mother was taken to an emergency room recently to determine whether her arm pain might signal a heart attack (it didn’t) a cardiologist prescribed five new drugs — including an opioid — to the small dose of a diuretic she had been taking to control her blood pressure.

Brownlee, senior vice president of the , a Boston-based group that seeks to improve health care quality by reducing unnecessary treatment, said that when her brother questioned the necessity of so many new drugs for a woman in her late 80s, the specialist replied frostily, “I don’t see anything wrong with prescribing lots of medication to older people.”

Bring The Pill Bottles

“This problem has gotten worse because the average American is on a lot more medications than 15 years ago,” said cardiologist Rita Redberg, a professor of medicine at the University of California at San Francisco.

Studies bolster Redberg’s contention: A found that the share of Americans of all ages who regularly took at least five prescription drugs nearly doubled between 2000 and 2012, from 8 percent to 15 percent. University of Michigan researchers recently reported that the percentage of people older than 65 taking at least three psychiatric drugs in the nine years beginning in 2004. Nearly half of those taking the potent medications, which include antipsychotic drugs used to treat schizophrenia, had no mental health diagnosis.

Redberg and other doctors are trying to counter the blizzard of prescriptions through a grass-roots movement called “” —聽systematically discontinuing medicines that are inappropriate, duplicative or unnecessary.

Interest in deprescribing, which was pioneered in Canada and , is growing in the United States, bolstered by physician-led聽efforts, such as the five-year-old campaign. The , a list of overused and potentially unsafe drugs for seniors first published in 1991, has been followed by aimed at curbing unnecessary drug use.

“Lots of different medications get started for reasons that are never supported by evidence,” said Redberg, editor in chief of JAMA Internal Medicine. “In general, we like the idea of taking a pill” a lot better than non-drug measures, such as improved eating habits or exercise.

“That’s what we were taught as physicians: to prescribe drugs,” said Ranit Mishori, a professor of family medicine at Georgetown University and a . “We are definitely not taught how to take people off meds.”

Kathryn McGrath, a Philadelphia geriatrician, said she tries to begin every appointment with a review of medications, which she asks patients to bring with them. “I think having the pill bottles” is much more powerful than a list, said McGrath, who has written about safely.

Although support is growing, deprescribing faces formidable obstacles.

Among them, experts say, is a paucity of research about how best to do it, relentless advertising that encourages consumers to ask their doctors for new drugs, and a strong disinclination – baked into the culture of medicine — to countermand what another physician has ordered. Time constraints play a significant role. So do performance measures that are viewed as a mandate to prescribe drugs even when they make virtually no sense, such as giving statins to terminally ill patients.

A Reluctance To Overrule

“There’s a reluctance to tinker or change things too much,” said University of Michigan geriatric psychiatrist Donovan Maust, who labels the phenomenon “clinical inertia.” When inheriting a new patient, Maust said, doctors tend to assume that if a colleague prescribed a drug, there must be a good reason for it — even if they don’t know what it is. Maust said he tries to combat inertia by writing time-limited orders for medication.

He recently began treating a man in his 80s with dementia who was taking eight psychiatric drugs — each of which can cause significant side effects and most of which had been prescribed for undetermined reasons.

“It’s very typical to see a patient who has a few episodes of reflux and is then put on a [proton pump inhibitor, or PPI] and a few years later are still taking it,” said Georgetown’s Mishori. Many experts say the heartburn drugs , and studies have to fractures, dementia and premature death.

“This is a cultural problem and an awareness problem exacerbated by the fragmentation of care,” said Brownlee, the author of “.” Many doctors, she added, have never heard of deprescribing.

Before his death several years ago, doctors advised Brownlee’s father, a hospice patient, to continue taking a statin, along with several other medications. None would improve or extend his life, and all had potentially harmful side effects.

Rx: What For?

Older people taking lots of medication was what Canadian pharmacist Barbara Farrell encountered when she began working at a geriatric hospital in Ottawa nearly two decades ago. Her experience, she said, was a catalyst for the Canadian Deprescribing Network, a consortium of researchers, physicians, pharmacists and health advocates she co-founded. The group seeks to drastically reduce inappropriate medication use among Canadian seniors by 2020.

Farrell, a clinical scientist at the Bruyere Research Institute, has also helped , used by doctors in the United States and other countries, to safely deprescribe certain classes of widely used drugs, including proton pump inhibitors and sedatives.

“I’ve found a lot of receptivity” to the guidelines among physicians, Farrell said. “We know there are pockets around Canada and the world where they’re being implemented.”

One of Farrell’s most memorable successes involved a woman in her late 70s who was using a wheelchair and was nearly comatose.

“She would literally slide out of her chair,” Farrell recalled. The woman was taking 27 drugs four times per day and had been diagnosed with dementia and a host of other ailments.

After reviewing her medications, Farrell and her colleagues were able to weed out duplicative and potentially harmful drugs and reduce the doses of others. A year later, the woman was “like a different person”: She was able to walk with a cane and live mostly independently, and she reported that her doctor said she did not have dementia after all.

When Farrell asked another patient why she was taking thyroid medication, the woman replied that her doctor had prescribed it for weight loss after her last pregnancy — in 1955.

“The patients I see are the tip of the iceberg,” Farrell said.

One way to facilitate deprescribing, Farrell said, is to require doctors to record why a drug is being prescribed, a proposal the deprescribing network has made to Canadian health officials. A by a team from the Boston VA Healthcare System found strong support among doctors for this concept.

While some doctors are reluctant to discontinue medications, patients can be wary, too.

“They may say, ‘I tried stopping my sleeping pill and I couldn’t sleep the next night, so I figured I needed it,'” Farrell said. ” Nobody explained to them that , which can occur after stopping sleeping pills, lasts three to five days.”

Mishori said that she deprescribes only one medication at a time so she can detect any problem that arises from that change. And, she adds, “I never take people off of a medication without doing something else.” In the case of heartburn drugs, she might first recommend taking the drug only when needed, not continuously. Or she might suggest a safer alternative, such as an over-the-counter antacid tablet.

Maust, the geriatric psychiatrist, recommends that doctors actively focus on “the big picture” and carefully weigh whether the benefits of a drug outweigh its risks.

“In geriatrics,” he said, “less is more.”

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But over the past two years, the issue of overlapping surgery 鈥� in which a doctor operates on two patients in different rooms during the same time period 鈥� has ignited an impassioned debate in the medical community, attracted聽聽by the powerful Senate Finance Committee that oversees Medicare and Medicaid, and prompted some hospitals, including the University of Virginia’s, to circumscribe the practice.

Known as “running two rooms” 鈥� or double-booked, simultaneous or concurrent surgery 鈥� the practice occurs in teaching hospitals where senior attending surgeons delegate trainees 鈥� usually residents or fellows 鈥� to perform parts of one surgery while the attending surgeon works on a second patient in another operating room. Sometimes senior surgeons aren’t even in the OR and are seeing patients elsewhere.

Hospitals decide whether to allow the practice and are primarily responsible for policing it. Medicare billing rules permit it as long as the attending surgeon is present during the critical portion of each operation 鈥� and that portion is defined by the surgeon. And while it occurs in many specialties, double-booking is believed to be most common in orthopedics, cardiac surgery and neurosurgery.

The issue was catapulted into public consciousness in October 2015 by an exhaustive聽聽of concurrent surgery at Harvard’s famed Massachusetts General Hospital by The Boston Globe. The validity of the story has been vehemently聽by hospital officials who defend their care as safe and appropriate.

The article detailed concerns by some doctors and other hospital staff about complications 鈥� including one patient who was paralyzed and two who died 鈥� possibly linked to double-booking over a 10-year period. It described patients waiting under anesthesia for prolonged periods and surgeons who could not be located, leaving residents or fellows to perform surgeries without supervision.

Patients who signed standard consent forms said they were not told their surgeries were double-booked; some said they would never have agreed had they known.

The practice has also figured prominently in cases in South Florida, Nashville and, most recently,聽

Critics of the practice, who include some surgeons and patient-safety advocates, say that double-booking adds unnecessary risk, erodes trust and primarily enriches specialists. Surgery, they say, is not piecework and cannot be scheduled like trains: Unexpected complications are not uncommon.

All patients “deserve the sole and undivided attention of the surgeon, and that trumps all other considerations,” said Michael Mulholland, chair of surgery at the University of Michigan Health System, which halted 颅double-booking a decade ago. Surgeons might leave the room when a patient’s incision is being closed, Mulholland said. A computerized system records the doctor’s entry and exit.

“It doesn’t do any good to check out your surgeon if they’re not even going to be in the room,” said Lisa McGiffert, director of Consumers Union’s聽. “We all know about the dangers of multitasking. This adds a layer of danger if you have the most expert person coming in and out.”

Indiana orthopedic surgeon James Rickert regards double-booking as a form of bait-and-switch. “The only reason it has continued is that patients are asleep,” said Rickert, president of the聽, a doctor group.

“Having a fellow so you can run two rooms helps augment your income,” he added. “You can bill for six procedures: You do three and the fellow does three.” The critical portion of the operation required by Medicare and designated by the surgeon can mean “running in and checking two screws for 10 seconds.”

Defenders of the practice, which has been the subject of a handful of studies with mixed results, say it can be done safely and allows more patients to receive care.

“It’s extremely important for us to make sure [all surgeries are] done with the highest quality,” said Peter Dunn, Mass General’s executive medical director of perioperative administration. Officials at his hospital, Dunn said in a recent interview, have “never traced back a quality issue” to concurrent surgery, which involves a minority of procedures.

Mass General complies with all applicable guidelines and regulations, Dunn said. The hospital now explicitly requires doctors to inform patients if an operation will overlap as part of the consent process, which may occur just before the start of surgery.

In January, a聽聽found that a Mass General spine surgeon who failed to inform a 45-year-old financial analyst that he was running two rooms was not responsible for the patient’s subsequent quadriplegia.

Divided Attention

No one knows how many of the nation’s 4,900 hospitals that receive Medicare payments 鈥� about 1,000 of which are teaching hospitals 鈥� allow the practice, the Senate Finance Committee noted in a recent report. The committee called on hospitals to adopt stronger policies and consent forms that go beyond opaque boilerplate statements that grant broad permission without specifying who is doing what. And the report noted that concurrent surgery may also occur in outpatient surgery centers and non-teaching hospitals and that it can involve patients who are not covered by Medicare.

The practice surprised some primary care doctors and a veteran medical ethicist.

“I certainly knew that for many procedures, residents might be involved,” said Arthur Caplan, a professor of bioethics at NYU School of Medicine. (NYU Langone Medical Center does not permit concurrent surgery.) “But I was a little taken aback that the attending surgeon was not in the room.”

Proponents say that overlapping operations can improve efficiency and better utilize a surgeon’s valuable time.

“Much of surgery is team-based,” said David Hoyt, executive director of the American College of Surgeons (ACS), which last year issued聽聽concurrent surgery. Largely similar to Medicare rules, the guidelines state that surgeons should inform patients of overlapping operations.

Robert Cima, a colorectal surgeon and medical director of surgical outcomes research at the Mayo Clinic, agrees. Overlapping surgery has been used safely since Mayo’s inception more than 100 years ago, he said.聽聽he co-authored found that 11,000 overlapping operations at Mayo did not have a higher death rate than non-overlapping surgeries.

Allowing qualified junior doctors to perform parts of an operation, Cima said, is vital in “training the next generation of surgeons.” Determining what portion of an operation is critical should be left to the individual surgeon, he said, not defined by Medicare or insurers, because it can vary from patient to patient.

But L.D. Britt, a past president of the ACS and chairman of surgery at Eastern Virginia Medical School in Norfolk, says that efficiency has little to do with concurrency. “Unless you’re closing, that surgeon should be there,” he said. “Most [surgeons] are doing it for lifestyle.”

Indiana’s Rickert and Britt say they are troubled by what they regard as a double standard: Very few surgeons would consent to the practice for themselves or a relative. “This happens to the Medicaid patient,” Rickert said, “not the partner’s wife.”

He advocates that Medicare and insurers define the critical portion requiring the presence of an attending surgeon as being everything between the making of an incision and the start of its closure, a task frequently performed by residents. “The critical components should not depend on whether the surgeon has opera tickets that night.”

Ghost Surgery?

Some surgeons say they are troubled by the resemblance of double-booking to a practice known as “” in which patients learn, usually after something goes wrong, that someone other than the surgeon they hired performed their operation.

In April, a Seattle jury awarded an anesthesiologist and her husband聽聽for botched abdominal surgery that disfigured his penis. After his operation, the couple discovered that a crucial part of the procedure was performed by a fellow, not the senior surgeon to whom he had explicitly granted consent.

“I always prided myself in telling patients I would be there from the moment they went to sleep to the moment they woke up,” said Stanley Shapshay, a head and neck surgeon in Albany, N.Y., who co-authored a 2016 editorial opposing simultaneous surgery.

Many things can go wrong during “noncritical” portions of an operation, particularly if a resident or fellow is unsupervised, said Shapshay, a professor of otolaryngology at Albany Medical College. A major artery or nerve can be cut accidentally, he said. “By the time the surgeon [arrives, the damage] has already been done.”

Trainees, Shapshay observed, vary. “Some are very good, some are OK and some need more experience.”

His view was reinforced by his experience at a hospital in the Southeast several years ago. A senior surgeon he was visiting left in the middle of an operation, after telling a family that surgery had gone well. While he and Shapshay were having coffee, the surgeon received an urgent page and had to rush back to the OR to deal with a serious breathing problem. The family was later told only that an unexpected event had occurred, not that the attending had been out of the room.

“That illustrated to me very clearly that you don’t leave the OR until the patient has left the OR,” Shapshay said.

Adequate informed consent is essential, said Robin Diamond, senior vice president for patient safety and risk management at the Doctors Company, a California-based malpractice insurer that has begun tracking malpractice claims related to overlapping surgery. She expects such lawsuits will increase.

“I think it can be done safely and has been safe in many cases,” said Diamond, who has degrees in nursing and law. But surgeons who plan to run two rooms should obtain explicit consent from patients at least a week ahead of surgery, she said, not the day before or the day of, as is common, to allow time to reconsider.

“It’s a basic patient right to know” who is doing their operation, Diamond said.

Patients don’t seem enamored of overlapping surgery. A聽by Harvard researchers found that fewer than 4 percent of 1,454 people had heard of concurrent surgery and that only 31 percent supported the practice; 95 percent said it should be disclosed in advance.

A Surprising Result

After the fallout at Mass General, officials at U.Va. decided it was time to largely eliminate concurrent surgery in all specialties; the practice had been most common in orthopedics.

In return for an end to simultaneous surgeries, hospital executives agreed that orthopedic surgeons would not be “disadvantaged,” said Richard Shannon, executive vice president for health affairs at U.Va. Part of the process involved overhauling the way surgeries were scheduled.

“It was an important wake-up call,” Shannon said of the controversy. “We wanted to redesign our system to eliminate the risk” as part of a larger聽.

Eliminating most concurrent procedures, Shannon said, actually resulted in an increase of 560 surgeries in 2016 over 2015, using the same number of operating rooms. “Concurrency was masking an efficiency problem,” said Shannon, who plans to publish the results of U.Va.’s efforts. “There was a lot of waste.”

“This debunks the urban legend” that overlapping surgery is more efficient, he said. “Like many things in health care, if you apply a rigorous disciplined approach, you may get an answer you didn’t expect.”

Rickert and others advise patients who want to avoid overlap to ask detailed questions well in advance and to put their request in writing and on the consent form.

“If you say, 鈥業 want only you to do the surgery,’ doctors will typically do it,’” Rickert said. “They want the business.”

He also recommends asking, “Are you going to be in the room the entire time during my surgery?” and then repeating that statement in front of the OR nurses the day of surgery. “If the doctor’s not willing to say yes, vote with your feet.”

If a surgeon says he or she will be “present” or “immediately available,” a patient should ask what that means. It may mean that the surgeon is somewhere on a sprawling hospital campus but not in 鈥� or even near 鈥� your operating room.

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Instead, Crisp spent weeks in a coma and underwent five surgeries to correct a near-fatal cascade of medical errors that left her with permanent injuries. Desperate for an explanation, Crisp, who is also a lawyer, said she repeatedly encountered a white wall of silence: The hospital and her surgeon refused to say little more than “things didn’t go well.” Crisp 聽piecing together what happened. “I decided I was going to find out even if it takes the rest of my life,” she said.

Jack Gentry said he “went into the hospital a patient and came out a victim.” In 2013, the retired Baltimore police officer suffered a catastrophic spinal cord injury during disk replacement surgery at MedStar Union Memorial Hospital that left him a quadriplegic.

But unlike Crisp, Gentry and his wife, a nurse, were immediately told what had gone wrong by his surgeon, who apologized for the error. The hospital covered Gentry’s rehabilitation and other major expenses and paid an undisclosed amount in compensation, all without litigation.

“When hospitals mess up, they need to do the right thing,” Gentry said. “MedStar did.”

For patients and their families killed or maimed by medical errors, Crisp’s experience 鈥� in which doctors clam up and hospitals deny wrongdoing and aggressively defend their care 鈥� remains standard operating procedure in most institutions.

But spurred by concerns about the “deny and defend” model 鈥� including its cost, lack of transparency and the perpetuation of errors 鈥� programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular. Researchers at Johns Hopkins University in Baltimore recently estimated that medical mistakes , which would make them the third-leading cause of death. Traditionally, the only way for patients to find out what went wrong has been to sue.

A blueprint for the approach used in Gentry’s case is being promoted by the federal Agency for Healthcare Research and Quality. Called , an acronym for Communication and Optimal Resolution, the approach is modeled on a long-standing program pioneered at the University of Michigan. It was tested in 14 hospitals around the country, including MedStar’s Washington Hospital Center and Georgetown University Hospital.

Although they differ, these programs 鈥� which typically feature prompt investigation of errors whose findings are shared with the victims, as well as an apology and compensation for injuries 鈥� are operating at the University of Illinois at Chicago, Stanford and and outpatient groups in Massachusetts. Despite fears that the new approach would encourage lawsuits, the opposite has proved true. , the number of lawsuits was cut nearly in half, and the hospital system saved about $2 million in litigation costs in the first year after the new model was adopted in 2001.

“The whole point of this isn’t to drop malpractice costs, it’s to drive patient safety,” said Richard Boothman, the University of Michigan Health System’s executive director of clinical safety and chief risk officer, who launched the program after a career defending doctors and hospitals. “We need to hard-wire as quickly as possible the lessons of these cases.”

In most hospitals, Boothman said, patient safety experts do not routinely talk to risk managers who handle malpractice claims. As a result, valuable information about preventing errors is lost.

In The Dark

Most patients never learn they are victims of a medical error. A landmark 1991 Harvard study found that of people harmed by errors file a lawsuit. Those who do face daunting odds: Patients lose of malpractice cases. Huge , combined with laws that have reduced damage awards in many states, have left many because plaintiffs’ lawyers are paid on contingency. Malpractice cases typically take three or more years to resolve. In the interim, many injured people struggle to pay for care.

Litigation “is a tortuous process for patients and health care workers,” said , who spent five years seeking answers about the 2003 death of her newborn son from a Chicago hospital that denied any wrongdoing.

“We later learned that this had happened to a family before us and another seven months after,” said Daley Ullem, a former McKinsey & Co. consultant whose ruptured uterus went untreated for an hour. She said she received a $4 million settlement before trial, which she offered to give back to the hospital to fund safety improvements. The hospital refused.

Disclosure efforts also face stiff resistance from doctors, insurers and lawyers, including defense attorneys for whom speedier resolution means fewer billable hours.

Despite laws in most states that prevent apologies from being used against doctors in lawsuits, many worry that it will make patients more likely to file suit, said Thomas Gallagher, a University of Washington professor of medicine who has written extensively about disclosure. A recent study found that of 300 primary-care doctors would not fully disclose a delayed breast cancer diagnosis to a patient.

Doug Wojcieszak 鈥� who founded an Illinois-based disclosure advocacy group called “Sorry Works!” 鈥� said one Iowa doctor told him that if he started apologizing when things went wrong, “he’d be doing nothing else all day long.”

Insurers are also leery, said Brian Atchinson, president of Physician Insurers Association of America, the trade association for liability insurers, which was involved in the development of CANDOR. “Some states are more conducive to this than others,” he said. “But there are those who don’t believe the benefits outweigh the risks.”

Lawyer Joanne Doroshow, director of the at New York Law School, expressed worry聽that disclosure programs may take advantage of vulnerable patients who are not represented by a lawyer. “The hospitals are in control of it, and it’s still in their interest to try and limit compensation to patients,” she said.

Jeffrey Catalano, a Massachusetts plaintiffs’ lawyer who is president of the state bar and a participant in that state’s disclosure program, says that patients should be represented early in the process. “I think if there’s a good attorney present, there’s no way a client is going to be shortchanged,” he said. “Good attorneys know this: Medical malpractice cases are hard to take to trial. If a client can get $1 now rather than risking getting nothing [at trial] for the prospect of $1.50 later, it may be better to take the $1 now.”

Doing The Right Thing

The country’s began 30 years ago with a doctor’s desire to do the right thing.

Pulmonologist Steve Kraman, newly named as chief of staff for what is now the Lexington Veterans Affairs Medical Center in Kentucky, said he faced a problem in 1987: how to handle the death of a middle-aged woman caused by an “undeniable error,”聽a massive overdose of potassium.

“If we had said nothing, [the family] never would have known a thing,” said Kraman, who was also the hospital’s risk manager. “We never would have gotten sued. But I just didn’t feel that was right.” So he suggested to the hospital’s lawyer that they come clean to the patient’s two adult daughters, from whom she was estranged.

“I sat down and told them exactly what happened, that we were responsible for it, that they should hire a lawyer and we were going to negotiate a payment,” he recalled. Two months later, the family was paid $250,000.

From then on, Kraman said, all cases involving errors were handled similarly. “We paid out for things that nobody could have sued for in their wildest dreams,” said Kraman, who is now a professor at the University of Kentucky. Some patients declined the cash, he said, because they feared it would “ruin their relationship with the doctor.” Kraman said he refused to pay a dime in cases where no injury could be proved. “That just alienates doctors and nurses who feel like you’re throwing them under the bus.”

Kraman said he had several advantages: Doctors were employed and insured by the VA system. Payments, which averaged $16,000, were made from the U.S. Treasury, not the hospital coffers. And the program had the support of the hospital’s director and lawyer as well as the U.S. attorney for Kentucky.

“This has to be done from the top down” or it won’t work, Kraman said. “The message has to be ‘This is how we do business.'”

When Boothman arrived at the University of Michigan in 2001 鈥� after two decades defending doctors, including an orthopedic surgeon who had been sued 21 times 鈥� he decided to try a similar approach. That included encouraging staff to report errors and bad outcomes; reports jumped from 2,400 a year to more than 34,000.

“You have to normalize honesty,” Boothman said, “to create a culture of continuous improvement.” Applying the lessons gleaned from those errors, he said, has helped make care safer.

“Litigating a case for three years and telling everybody, ‘Don’t talk about it and don’t change anything,’ is immoral and counterproductive,” he added. “I don’t serve my organization well by defending care we shouldn’t be defending.”

“Today we’re often at the bedside as soon as things happen,” he said. Patients and their families are interviewed as part of the hospital’s investigation of the facts, something that does not happen in traditional litigation.

Like Kraman, Boothman said he worries that some hospitals are using disclosure to cherry-pick small or unwinnable cases, not as a standard approach.

A Test Case

Orthopedic surgeon P. Justin Tortolani remembers with sickening clarity the moment he realized that a device he was installing had gone too far, penetrating Jack Gentry’s spine. The 60-year-old retired police officer, who once had hiked the entire Appalachian Trail, was instantly paralyzed from the neck down.

“You can’t really believe it’s happening,” said Tortolani, Union Memorial’s director of spine surgery. Summoning his years of training, the surgeon formulated a plan and steeled himself to tell Teresa Gentry what had happened. It was the first of many conversations about the accident that he would have with the family.

“We didn’t want to go through litigation, we didn’t need to go through litigation,” said Larry Smith, MedStar’s vice president for risk management. MedStar uses CANDOR in about a dozen cases with substantial damages annually.

MedStar executives “told me what had happened, why it happened, that it was directly or indirectly their fault and that whatever I needed I should ask for,” Gentry recalled. MedStar paid for five months of inpatient rehab 鈥� Gentry’s insurance would have covered only two weeks 鈥� modifications to the couple’s home, a $45,000 wheelchair and a new wheelchair-accessible van. It provided a case manager, a home-care nurse and $15,000 for incidental medical expenses.

“Because of the nature of Jack’s injury, we would have had to mortgage everything to pay for his care” otherwise, Teresa Gentry said.

Early on, Gentry said, his older brother, a Baltimore malpractice lawyer, expressed bafflement at MedStar’s approach. “He said as long as we were getting what we needed, to just go with it,” Gentry recalled.

At the end of two years, the case was settled with a confidential payment negotiated by lawyers for the couple, MedStar and the device manufacturer.

“I felt like it would take care of Jack for the rest of his life,” said Teresa Gentry, adding that the couple had been prepared to file a lawsuit if an agreement could not be reached. “Did I get enough to pay for everybody’s pain and suffering and trauma?聽No.”

“I was very skeptical in the beginning of this whole process,” she recalled, but she said she believes it has worked well, as does her husband.

Tortolani said he feels “remorse, guilt and sorrow for Jack and his family. This shakes you to your core,” he said. MedStar officials have been “unbelievably supportive,” Tortolani said, and he remains deeply grateful to the Gentrys. “My relationship with Jack has never been stronger.”

Donna Helen Crisp says she thinks she would have been less traumatized had the North Carolina hospital and her surgeon not stonewalled her. “I would have been deeply depressed that I had such a bad experience, but I could have moved on with my life,” said Crisp, who has written a book about her experience entitled “Anatomy of Medical Errors: the Patient in Room 2.” Being denied the truth left her with “no way to put it into perspective.”

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Often called device reps — or by the more cumbersome and less transparent moniker “”聽— these salespeople are employed by the companies that make medical devices: Stryker, Johnson & Johnson and Medtronic, to name a few. Their presence in the OR, particularly common in orthopedics and neurosurgery, is part of the equipment packages that聽hospitals typically buy.

Many “people who don’t work in health care don’t realize that industry reps are sometimes in the OR,” said Josephine Wergin, a risk management analyst for the ,聽a Pennsylvania nonprofit that conducts research on medical subjects for the health care industry. “A lot of times they are the real experts on their products.”

Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, experts say, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their 听诲别辫别苍诲.

Although they don’t scrub in, reps are expected to be intimately familiar with the equipment they sell, making sure it is at the ready for the surgeon and poised to answer technical questions.

Who’s The Expert?

But how much influence do reps wield, how necessary and costly are their services and does their presence in the OR, which may not be disclosed to patients, raise ethical questions about informed consent? A 聽has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a who had not graduated from high school tried for three hours to fix a prosthetic hip while a surgeon allegedly left the OR.

Despite their role, device reps have received little scrutiny, in sharp contrast to drug salespeople, whose role has been the subject of considerable research.

“There’s so little public awareness of this,” said Adriane Fugh-Berman, an associate professor of pharmacology at the Georgetown University School of Medicine and director of , a project that focuses on prescribing and drug-marketing practices. Fugh-Berman is the coauthor of a 聽that raises questions about whether surgeons rely too heavily on reps for technical聽expertise and assistance, to the potential detriment of patients.

But the cost of medical devices, an industry with about , combined with concerns about conflicts of interest by doctors who as part of the Affordable Care Act, has resulted in increased scrutiny, as hospitals from Savannah to Stanford聽seek to standardize and circumscribe the activities of device salespeople.

Several high-profile lawsuits have played a role, among them a 2006 Ohio case in which a surgeon and a rep were ordered to pay a patient $1.75 million after botched brain surgery. The salesperson had wrongly assured the surgeon that a bone cement was suitable for sealing a hole in the patient’s skull. In 2003, Endovascular Technologies pleaded guilty to 10 felonies in federal court and paid more than $92 million in criminal and civil penalties for covering up problems including 12 deaths associated with an abdominal device. Doctors had been removing the device using that had never been approved by the Food and Drug Administration.

Some hospitals, most notably Loma Linda University Medical Center in California, have in orthopedics, buying implants directly from the manufacturer at a substantial discount and training surgical technicians to take their place in the OR. Loma Linda’s chief of orthopedics said the hospital has saved about $1 million annually, a savings of 聽on the cost of the devices, without affecting outcomes.

“I think there is a role” for reps, said Lisa McGiffert, director of the Consumer Reports . But, she added, when it comes to choosing the best device — such as a prosthetic knee — “can the patient trust that they’re getting the expertise of the doctor or the influence of the rep?”

The presence of device reps in the OR, she added, also raises questions about the adequacy of consent, if patients are not explicitly informed of their presence.

Learning On The Fly

ECRI recently repeated its recommendation that hospitals obtain explicit written consent from patients if reps are to be present and warned surgeons against learning “how to use … devices on the fly.”

How often that happens is unclear, because what happens in the OR tends to stay in the OR. A suggests that reps’ over-involvement is not uncommon.

A survey conducted by researchers at New York’s Albany Medical College found that 88 percent of 43 device reps said they had provided verbal instructions to a doctor during surgery, while 37 percent had participated in a surgery in which they felt their involvement was excessive, often because the surgeon lacked sufficient expertise. Twenty-one percent said they had direct physical contact with hospital staff or a patient during an operation, which could violate hospital policy as well as state law.

Terry Chang, associate general counsel of , a device industry trade association, points to its code of ethics as well as 聽issued by the American College of Surgeons, which state that reps are to refrain from medical decision-making and participating in surgery.

But Chang says that reps, who have witnessed dozens if not hundreds of the same procedures, provide an essential benefit for doctors and patients. They “are only present at the behest of the physician and only as a trainer,” and they provide “a live interactive resource.”

Their value, Chang said, lies in their expertise, which can make surgery faster and more efficient. “For a lot of institutions, it’s a bandwidth issue,” he said, echoing a finding in Fugh-Berman’s study that some surgeons prefer working with reps because they are more knowledgeable than hospital staff.

Gerald Williams, a Philadelphia joint replacement specialist who is president of the 18,000-member , agrees. “Even if a surgeon is extremely familiar” with a device, “there are different teams scrubbing in” who typically have less familiarity with the procedure and the surgeon’s process than a rep with whom a surgeon regularly works.

“Their presence is dictated by the complexity of the surgery,” he said. “They are probably there close to 100 percent in complicated cases such as spine surgery and joint implants.”

Williams said he doesn’t tell his patients that a rep will be in the room, adding, “I don’t tell them there’s a circulating nurse, either. My patients look at me as being the captain of the ship. I think if I told them about a rep, they would all be supportive of it.”

While salespeople have been in operating rooms for decades, their participation mushroomed beginning in the late 1990s with the proliferation of total joint replacement operations, said Linda Groah, the longtime executive director of , the Association of periOperative Registered Nurses.

These days, “there’s much more control of the reps,” she said. “They just don’t come through willy-nilly.'”

But Jeffrey Bedard’s 2014 study about their role in the OR makes it clear that in some cases, there may be a chasm between guidelines and actual practice.

Bedard, who conducted his research as a graduate student in medical ethics, said it was prompted by his experience as an orthopedic device rep in the late 1990s. He subsequently became a drug salesman and now works in the pharmaceutical industry.

Bedard vividly remembers participating in one case involving a patient in her mid-40s. The surgeon, with whom he had not previously worked, refused all preoperative training, including watching a video, on a new $10,000 hip replacement system. “He said, ‘You’re going to be there, right?'” Bedard remembers being asked.

“To say that the case was a train wreck would be an understatement,” Bedard recalls. The surgeon repeatedly cursed at him and at the circulating nurse, who continually monitors the patient and is responsible for ensuring that the proper equipment is available, as he struggled to perform the procedure. “I had to hold up the illustrated surgical technique and talk him through the case step by step,” Bedard remembered. “I was absolutely beside myself.”

Bedard recalled that when he called his supervisor to report what had happened, “my boss said: ‘You just made $1,000 for three hours’ worth of work. What are you complaining about?'”

Judging by the responses to his anonymous survey, which found that 37 percent of reps said they believed they had been excessively involved in an operation and 40 percent had attended a surgery in which they questioned the surgeon’s competence, Bedard said little appears to have changed. “As a rep,” he said, “you’re paid to sell, to grow your business.”

Two years ago, Gary Botimer, a joint replacement specialist who is chief of orthopedics at Loma Linda, undertook a radical experiment: He got rid of reps in joint replacement cases. Botimer negotiated a steep discount on the price of artificial joints bought in bulk from a well-known American manufacturer and sent hospital surgical techs to the technical training given to device salespeople.

“It took me two years to convince the administration” to do this, recalled Botimer, who said that one surgeon, who had significant financial ties to a manufacturer, quit. “I took a lot of bullets.”

“What we basically did is to take the skill set of the reps and replace it with our own employees, who don’t have a conflict of interest,” Botimer said. “It’s very easy to train your own people. We have found that the techs are better than the reps.”

The ‘Rep-Less Model’

To lay the groundwork, Botimer said he and other surgeons reviewed the literature to select the best implants as the hospital’s standard. After the program was launched in 2014, Botimer said, he and his staff tracked the outcomes of all 500 joint replacement cases for one year to see if the “rep-less model” was equivalent. No difference in outcomes was detected, he said, but the hospital saved $1 million each year. (While standard implants are used in about 90 percent of cases, Loma Linda surgeons are free to use other devices if they believe doing so is in the patient’s best interest.)

The program has been so successful that it is being extended to other orthopedic surgeries, such as trauma and spine operations, he said. Botimer added that he is fielding inquiries from other hospital systems contemplating a similar move.

“This is a big change in the culture, and no one makes that change easily,” he said. “You have operating [room] personnel who’ve only known one way of doing things, doctors who are afraid to try it and administrators worried that docs would turn on them. We’ve spent a couple of years proving to everybody that their worst fears didn’t happen.”

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In 2003, beset by $30,000 in tuition debt and imbued with a burst of altruism, Eastman, a college senior, decided to donate her eggs to help an infertile couple have a baby. Over the next decade she donated nine more times, earning a total of about $20,000 — money that helped Eastman and her then-husband buy a house.

“When I think back, I think, ‘God, how stupid was I?'” said Eastman, now 34, who works as a 911 operator near Seattle. She made her final donation in 2013, months before she was diagnosed with Stage 4 metastatic breast cancer — a rarity in someone so young who has no family history of the disease.

Eastman said that when she asked her oncologist whether her cancer might be related to her egg donation, which involves the use of hormones to , he replied that he didn’t know, adding, “Well, there are risks.”

Although Eastman believes that being an egg donor was the cause of her estrogen-fueled cancer, experts say it is impossible to know. Studies of the long-term impact of egg donation on donors have never been done, even though the practice dates back more than 30 years.

Despite sporadic reports of subsequent infertility and a variety of cancers, , it isn’t known whether these problems are linked to the process or are simply the result of chance.

Fertility specialists say that egg donation is safe and involves the same process as , which uses drugs to stimulate and regulate egg production. A 聽of 25 studies seeking to evaluate the risks between ovarian cancer and the use of fertility drugs found “no convincing evidence” of an increase in the risk of invasive ovarian cancer.

“There are no long-term adverse risks of IVF” or egg donation, said Richard J. Paulson, president-elect of the (ASRM), which represents fertility specialists. Paulson heads the infertility program at the University of Southern California, one of the nation’s oldest egg donor programs, which was established in 1986. “All the data we have so far seem to indicate no long-term problems.”

But others say the matter remains unsettled because donors haven’t been studied.

“There is a total lack of information about the long-term [effects],” said Timothy R. B. Johnson, the longtime chairman of the department of obstetrics and gynecology at the University of Michigan Medical School.

Johnson supports the establishment of a national registry to track the health of egg donors. “No one’s collecting the data” on donors, he said, adding that the fertility industry is largely unregulated. Once their eggs are retrieved, donors are sent home with little or no follow-up.

A transaction once shrouded in secrecy, the internet now hosts a thriving and , largely supplanting leaflets on college bulletin boards and ads in campus newspapers, the traditional methods of recruiting fertile young women. Payment varies, currently starting at about $3,500 per cycle and sometimes exceeding $50,000, depending on the location of the clinic or egg brokerage and the donor’s characteristics. An Ivy League education, Asian descent (there is a paucity of donors), exceptional looks and a previous donation that led to a birth command higher reimbursement.

The demand for donor eggs has increased rapidly in the past decade. Nearly every state has at least one fertility clinic, said Judith Daar, a specialist in reproductive law and a professor at Whittier Law School in Costa Mesa, California. A found a significant increase in the use of donor eggs between 2000 and 2010, from 10,801 to 18,306. Daar estimates that about 10,000 babies born in the United States in 2013 were conceived using donor eggs.

But questions about egg donation abound, said veteran women’s health advocate Judy Norsigian, a cofounder and former executive director of the Boston-based advocacy group . Among the unknowns: How many women have donated eggs? (The number is believed to be in the thousands.) How many times are they donating? (The ASRM recommends a lifetime maximum of six.) Which drugs are they being given, and in what doses? How common is ,聽a painful condition in which the ovaries swell? Severe cases can lead to a stroke or even, rarely, to death.

Informed Consent

It is also difficult, health advocates say, to gauge how aware potential donors are — or what they are told — about short- and long-term risks. A 聽of 80 donors found that “a rather large and troubling minority” — 20 percent — said they did not know of possible health risks. And while 8.8 percent said they knew that the process entailed some pain, 45 percent reported experiencing “notable pain.” A 聽of egg donation ads placed on Craiglist, one of the chief venues for egg donors, found that “the vast majority” do not include risk information.

Norsigian said she worries that donors are being falsely reassured that the process is safe, without being told that there is no definitive research.

“Absence of evidence of harm is not proof of safety,” she said. “Fertility doctors by and large don’t want to shine a light on what is a really lucrative field.”

Studies of IVF in infertile women have produced conflicting results: Some have found no increase in cancer, while others reported an of uterine and . The meaning of this finding is unclear, because infertility itself is a risk factor for some malignancies.

Some fertility specialists are cool to the idea of a registry, which they say is unnecessary. “I can’t even imagine logistically that such a thing would ever take place,” said Preston Sacks, a reproductive endocrinologist affiliated with Columbia Fertility Associates, which has three offices in the Washington, D.C. area. In Sacks’ view, concerns about medical privacy would prove insurmountable.

Judy E. Stern, a professor of pathology and obstetrics and gynecology at Dartmouth who oversees the, a voluntary database that includes about 70 egg donors, said she believes that donor data is urgently needed.

“I think if there had been huge health risks [from IVF], we would have seen that over the last 30 years,” she said. “That suggests the absolute risk is fairly low. But we don’t know anything about the donors,” whose risks may differ from infertile women undergoing IVF. “These are presumably fertile women and they may respond to medications [differently] than infertile聽women.”

Stern co-chairs an egg donor task force of the Society for Assisted Reproductive Technology, which represents clinics performing IVF. She said SART is considering the establishment of an egg donor registry. “If we don’t understand the risks for donors, we need to, because of the women who are freezing their eggs” for possible later use, she said.

How Naive?

Ari Laurel, now 26, donated her eggs to an Australian couple in 2014. Laurel said that she knew she didn’t want children and that Asian donors like her were in demand. Her $12,000 payment financed a year of graduate school. “The agency I went through seemed to ask eugenic-type questions” such as skin color and whether she had been in gifted programs. Laurel said she was聽also asked to submit her undergraduate transcript and GRE scores.

Laurel, who lives in Missoula, Montana, said she felt well informed by the clinic about possible health risks and suffered no complications. Before deciding to donate, she contacted , an online group founded in 2013, and spoke to one of its founders.

She has no regrets and is happy that she was able to help an infertile couple have a baby. But when the clinic contacted her for a second donation, Laurel declined. “I found the process pretty exploitative,” she said.

Her savvy is not typical of the 60 egg donors whom medical anthropologist Diane Tober has interviewed for a film she is making. Tober, an assistant professor of nursing at the University of California, San Francisco, said that some donors seemed naïve about the process, which many found more physically and emotionally daunting than they anticipated.

“They expected that the doctor and the staff was going to look out for them as they do for their infertility patients,” Tober said. The pitch was “cloaked in this language of ‘Be an angel, help someone and get paid for it.'” Some donors, she said, were motivated by altruism; others said “it would be so cool” to help gay men create a family.

In Tober’s view, egg donation more closely resembles kidney donation than sperm donation. Both egg and kidney donation, she said, “involve drugs and medical procedures that are of no benefit to the donor.”

Sacks, the Washington fertility specialist, said that about 10 percent of the prospective donors he evaluates decide against completing the process once he tells them what’s involved. Donors are paid $8,000 per cycle, he said, and have included a teacher, a lawyer with a major Washington firm and a school bus driver; few are college students.

After undergoing medical and psychological screening and being matched with a recipient, the donor takes birth control pills to synchronize her menstrual cycle with that of the recipient. After that, she typically , a hormone approved to treat advanced prostate cancer. Lupron, which prevents the ovaries from releasing an egg, is not approved for use in fertility procedures. Some women’s health advocates say they are concerned that donors are not told the drug is being used “off label” for an unapproved use. (Off-label use of drugs is common in all fields of medicine.) Lupron’s 聽have aroused concern; they include joint pain, acne and osteoporosis.

Lupron is followed by injections that stimulate egg production. After that comes a carefully timed “trigger shot” of a hormone that causes ovulation. Within roughly 48 hours, the donor is sedated and a needle is inserted transvaginally into the ovary to extract each egg. Typically no more than 20 eggs are harvested.

Thinking It Through

Clinical psychologist Andrea Mechanick Braverman, who screens donors for several Philadelphia area fertility clinics, said that one of her goals is to ensure that donors “know what they’re doing.” She worries that some underestimate the invasiveness of the procedures and the long-term emotional ramifications, such as feelings of regret. “You try to get them to think it聽through.”

Sindy Wei, 39, thought she had. Wei, an assistant professor of radiology at UCLA, donated her eggs in September 2001; she was then a 25-year-old M.D./Ph.D. student struggling to pay her rent in Los Angeles.

Wei, who has testified about her experience before a California Senate committee seeking greater protection for egg donors, said she researched the potential risks and found none.

“I didn’t know the research hadn’t been done because the donors hadn’t been followed,” Wei said. A San Francisco clinic paid her $6,500, she said, and extracted a whopping 60 eggs.

When Wei complained in the recovery room that she felt ill, she said doctors tried to discharge her and urged her to fly home to Southern California. Wei said she refused to leave, and eight hours later she was admitted to a hospital after her blood pressure plummeted because she was bleeding out. Doctors discovered that Wei’s ovarian artery had been nicked during the retrieval process and聽her abdomen had filled with blood. She received several transfusions and underwent emergency surgery, then spent several days in intensive care.

Wei was left with bladder spasms and infertility and underwent six rounds of fertility treatment when she was trying to get pregnant. She said her biggest fear is that she will develop cancer from the hormones she took as a donor and infertility patient.

“I think egg donation should be a choice for young women,” Wei said. “But they should really know what the risks are. And unless it’s studied, there’s no way to tell.”

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But Happli’s operation had to be aborted after it proved too difficult. Several months later, the pipe fitter, now 58, traveled to Froedtert Hospital in Milwaukee, 175 miles from his home. His operation, one of 127 Whipples done at Froedtert last year, was performed successfully by chief surgeon Douglas B. Evans.

The procedure involves removing part of the pancreas and small intestine as well as the gallbladder, and reconnecting the digestive organs. It proved to be particularly complicated in Happli’s case, Evans said, because of tissue damage caused by radiation treatment for his lymphoma.

“If this patient is not getting referred [to a specialist], then who is?” asked Evans, who said he has seen a recent uptick in patients treated unsuccessfully by inexperienced surgeons at smaller hospitals.

The largely unfettered ability of surgeons with minimal expertise to perform high-risk procedures — particularly at hospitals that lack experience caring for significant numbers of patients — has been the subject of a contentious, long-running battle known as the volume-outcome debate.

A groundbreaking found that patients who underwent operations at hospitals that did more of those surgeries had significantly lower death rates than those treated at hospitals where they were done infrequently. 聽has since been replicated repeatedly across many specialties and found to apply to surgeons as well as hospitals. Last month, a found that the risk of complications was far higher among surgeons who performed only one thyroid removal annually than among those who did 25 or more of the tricky procedures per year.

Recently the volume battle was reignited when a trio of prominent health systems — Johns Hopkins, Dartmouth-Hitchcock and the University of Michigan — pledged that they will require their surgeons and 20 affiliated hospitals to meet minimum annual thresholds for 10 high-risk procedures. The three systems have asked other hospital networks around the country to join them.

Under the terms of , believed to be the first of its kind, surgeons must perform at least five pancreatic cancer surgeries annually in hospitals where 20 such operations are done each year. For knee or hip replacements, the requirement is 25 per surgeon and 50 per hospital. There are provisions for emergency surgery and for surgeons who sometimes do not meet the threshold because they were on leave; such surgeons might be required to perform a certain number of procedures under聽supervision.

“There is this intractableness of patients undergoing surgical care in places that have no business doing it” or performed by “hobbyists” — surgeons who infrequently perform risky surgeries, said , chief academic officer at Dartmouth.聽Birkmeyer devised the pledge with , an internationally known expert who directs the Armstrong Institute for Patient Safety and Quality at Johns Hopkins.

At large teaching hospitals, Birkmeyer noted, “there are usually one or two or three surgeons who are recognized as go-to doctors” for certain procedures and do them frequently. “But there’s this tail of other surgeons who do only a few a year,” such as a shoulder surgeon who performs a handful of hip replacements or a breast cancer surgeon who occasionally attempts a Whipple.

“We decided to use volume as a pilot case, an initial foray into setting quality and safety standards,” he said. “And we wanted to do it in a way” that was not subject to the discretion of hospital officials.

Critical Information

As smaller community hospitals affiliate with larger ones, the questions of which surgeons should do which procedures and where are increasingly confronting health systems. Hospitals of all sizes — both large academic centers and smaller community institutions — face a variety of sometimes competing incentives: to retain lucrative surgical cases and to avoid angering surgeons, who fiercely prize autonomy and wield considerable clout because they generate substantial revenue. And while hospitals聽formerly reaped a if patients suffered complications and had to be readmitted, they now face penalties under the Affordable Care Act.

The , a nonprofit organization that represents large employers and purchasers of health care and seeks to advance patient safety, has focused on volume in its hospital rating system. “Volume is a really critical piece of information,” said the group’s chief executive officer, .

“I think every medical staff should be grappling with these volume benchmarks,” she said, endorsing the pledge. “It’s fundamental.”

Ashish K. Jha, a practicing internist and professor of health policy at Harvard’s T. H. Chan School of Public Health who has written about efforts to improve medical quality, calls the pledge “very reasonable.”

Low-volume hospitals, he said, typically lack specialized teams to care for patients as well as state-of-the-art equipment and systems designed to prevent or quickly spot complications — critical factors in improving outcomes. “None of us care about volume; we care about outcomes, and volume is a surrogate” measure of outcomes, Jha noted. “Even though we’ve been talking about this for 35 years, a ton of high-risk surgery still happens among low-volume providers.”

But surgeons’ groups and the president of the Joint Commission, the Chicago group that accredits the nation’s hospitals, have criticized the pledge as simplistic and overly prescriptive. Some officials say they fear it could unfairly penalize low-volume surgeons and smaller hospitals that have good outcomes.

“There’s room to improve in low-volume and high-volume hospitals,” said Kevin Bozic, chairman of the department of surgery at the Dell Medical School at the University of Texas at Austin, who heads the committee on research and quality for the American Academy of Orthopaedic Surgeons. “There are high-volume, low-quality hospitals” as well as the converse.

“I know Harvard may be better than McPherson, Kansas,” said Tyler Hughes, a surgeon at the 25-bed hospital in McPherson and a director of the American Board of Surgery. “But for many patients, the best possible surgery is closest to home.”

Irate Surgeons

Although patient-safety experts and some insurance companies have long encouraged patients, especially those with serious illnesses or complex diagnoses, to seek care from experienced specialists at high-volume hospitals, there is little to prevent doctors and hospitals from doing whichever surgeries (other than organ transplants) they see fit, no matter how rarely they do them.

Many patients don’t know to ask a doctor about volume or outcomes or are unable to ferret out relevant information when choosing a surgeon or hospital. One reason, Leapfrog’s Binder said, is that much important information such as complication rates remains hidden. Hospitals report detailed data about surgical outcomes to registries for internal use, but the information is not publicly available.

Kerry O’Connell, 59, a Denver construction executive, said that only after a botched elbow operation that required seven corrective surgeries did he learn that his was the second such procedure his orthopedist had performed. “I went to the one clinic where the ER sent me, and the surgeon seemed like a nice guy,” he said.

“We don’t have enough transparency in health care,” Binder said. “It’s the first thing everyone wants to know: Who’s the best surgeon? And anyone in health care picks up the phone and asks their friends.”

Recently, Binder notes, there have been new efforts to inform patients. In the past year, the journalism organization ProPublica and Consumer’s Checkbook have launched databases that rate surgeons. Since 1995 New York state has published some data on heart surgeons. And Consumer Reports and the federal government’s Hospital Compare website provide hospital-specific information.

A report by Leapfrog found that in 2013, one-third of hospitals that performed procedures to remove all or part of the esophagus, a demanding surgery to treat cancer, did only one or two annually, far below the level needed to achieve proficiency. A of an extremely low-volume Florida heart surgery program launched in 2011 found that six babies died in a two-year period, far more than expected; the program has since closed. And a last year found that Medicare patients who had knee replacements at the lowest-volume hospitals in the country were 70 percent more likely to die than those whose surgery was performed at the highest-volume centers; for hip replacement, the figure was 50 percent.

Disparities can be seen among hospitals in the same system, Birkmeyer noted.

“One of our highest priorities is insuring consistent quality and safety” regardless of where a patient seeks treatment, he said. In the past decade, Dartmouth has grown from a single hospital in Hanover, New Hampshire, to eight in northern New England. Baltimore-based Hopkins has affiliated with smaller hospitals in Washington, D.C. and suburban Maryland.

Among the most irate reactions Birkmeyer said he encountered came from about 10 surgeons affiliated with Dartmouth’s main hospital who were told they would no longer be allowed to do procedures for which they didn’t meet annual minimums. “They said things like, ‘I’ve been credentialed to do this for 20 years and I’ve never had a complication, and now you’re telling me I can’t do it?’ “

That anger and the months required to get the boards of hospitals and their executive committees to agree to the new rules may be among the reasons only three systems have signed on so far, Birkmeyer said. More than a dozen others have expressed interest.

Some surgeons say that the focus on volume is misguided.

The problem “is actually much more complicated than volume” said David Hoyt, executive director of the American College of Surgeons. Hoyt said that the group is drafting its own guidelines that will address volume.

Beyond Numbers

To Mark Chassin, president of the Joint Commission, the pledge misses the mark. “The surgeon’s contribution to the outcomes patients experience is only one component,” he said.

“Volume should never be used by an accrediting organization as a measure of quality” because it is too imperfect a measure, Chassin added.

Patients can help protect themselves, he added, by taking “as much responsibility and interest” as possible in their care.

In the view of general surgeon Linda Halderman, doctors are the best judges of their abilities. “Every surgeon has to exercise judgment of their own capabilities” and know when to refer to a more experienced colleague, said Halderman, who is based in Selma, California.

But Harvard’s Jha disagrees. Many surgeons, he said, tell him they “have excellent results and I’ll say, ‘How do you know? Do you actually track your outcomes?’ ” Most, he said, do not.

Two months ago, Linus Linaweaver, 76, chose to undergo elective abdominal surgery in his home town of McPherson, Kansas, after robotic prostate surgery at a larger hospital in Wichita nearly killed him and left him with a colostomy.

“I wanted to be back in our town,” he said, adding that he had confidence in Tyler Hughes, his surgeon, and McPherson Hospital. His seven-hour operation went well, and Linaweaver recently said he is “almost back to normal.”

James Happli is back at work after a year’s medical leave. Following his failed Whipple surgery, the local surgeon proposed trying again. That offer was withdrawn after a second specialist refused to participate. At that point, Happli was referred to Evans in Milwaukee.

If he had it to do over again, Happli said, “I would have gone to a bigger place” and a more experienced surgeon the first time.

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“I’d just read about how abdominal CTs are one of the highest-risk tests [in terms of radiation exposure] and should not be repeated unless there was a major change,” said Hanvik, who lives in Minneapolis. In the past, antibiotics and a bland diet had quelled her recurrent diverticulitis. Hanvik said she wanted to follow that approach again but avoid a scan, which contains about 10 millisieverts (mSv) of radiation, the rough equivalent of 听辞谤 .

“I don’t think she appreciated my uncharacteristic behavior,” said Hanvik, adding that her primary care doctor reluctantly agreed, but made her promise to return within 48 hours if she did not improve. Hanvik got better, as she had previously.

Hanvik’s newfound assertiveness and her questions about the necessity of a CT scan reflect a growing awareness of the potential pitfalls of diagnostic imaging, which in the past two decades has exploded into a .

Imaging has aided diagnosis and helped many patients avoid exploratory surgery, but it has also spawned concerns about misuse. Experts cite ballooning costs, including from duplicate procedures, potential harm from the tests themselves and the overtreatment of harmless conditions found during scans. These — so named because they are found unexpectedly — include聽benign lung and thyroid nodules and other common conditions that can lead to unnecessary and expensive workups as well as treatment that can cause complications.

Much of the attention has focused on , which use hundreds of X-rays to create detailed three-dimensional images that enable doctors to see things previously visible only through a biopsy or surgery.

Like X-rays and PET scans, CT scans use ionizing radiation, which can damage DNA and cause cancer. Two other imaging technologies, MRI scans and ultrasound, do not use radiation. CTs are used for a plethora of reasons, among them finding kidney stones, evaluating chest pain and detecting tumors or other abnormalities.

Widely hailed as one of the most important medical advances of the past century, CT scans were developed in the 1970s. Their use in the United States grew from 3 million in 1980 to in 2011.聽Although CT scans are an essential diagnostic tool, the Food and Drug Administration reports that an estimated of imaging tests are believed to be medically unnecessary.

“We have this view that we only really use imaging when it’s really necessary,” which is no longer the case, said Rebecca Smith-Bindman, a professor of radiology, epidemiology and obstetrics and gynecology at the University of California, San Francisco. “The truth is, now it’s ubiquitous. And many of these tests don’t need to be done.”

Like X-rays, CT scans represent a potentially significant health problem, one that experts say may not show up for years: cancer caused by radiation. In most cases, it is impossible to definitively attribute cancer to radiation exposure that occurred years or even decades earlier. And overall, the risk from a single scan is small: The that the additional risk of developing a fatal cancer from a scan is 1 in 2,000, while the lifetime risk of dying of cancer is 1 in 5.

The question of risk remains a matter of fierce debate among radiologists: Some say that the amount of radiation used in diagnostic studies is safe and that the benefits far outweigh the small chance that a person will develop cancer. But other experts, including Smith-Bindman, say that while patients should never avoid scans that are medically necessary, excessive radiation doses and indiscriminate use of imaging pose a clear and .

Studies published and by teams from Columbia University and the NCI predicted that up to 2 percent of future cancers — about 29,000 cases and 15,000 deaths annually — might be caused by CT scans. A by the Institute of Medicine found that the two environmental factors most strongly associated with breast cancer were radiation exposure and the use of post-menopausal hormones.

While a single scan would rarely be concerning, many Americans undergo multiple tests. A by researchers at Brigham and Women’s Hospital in Boston found that among 31,000 patients who had a diagnostic CT scan in 2007, 33 percent had more than five during their lifetime, 5 percent received 22 or more, and 1 percent underwent more than 38 scans.

From Necessity To Overuse

Some hospitals tend to perform double scans — one with a contrast agent and a second without it. Doctors sometimes refuse to accept or are unable to access radiology studies done elsewhere and send patients for duplicate tests at a facility in which they have an ownership interest. Doctors who have a in radiology clinics or who own scanners use imaging substantially more often than those who don’t, studies have found.聽And increasingly, specialists are requiring that patients get a scan before they first see a patient.

According to the FDA, which has launched an initiative to reduce unnecessary exposure to medical radiation, the effective doses from diagnostic CTs are “not much less than the lowest doses of 5 to 20 mSv received by some of the Japanese survivors of the atomic bombs” dropped over Hiroshima and Nagasaki in 1945. Some of these survivors have “demonstrated a small but increased radiation-related excess relative risk for cancer mortality.”

Radiation exposure is cumulative, and children, who undergo between annually,聽are much more vulnerable to its effects.

Concerns about overuse and potential harm have prompted actions by federal health officials as well as consumer and physician groups. These include the Image Wisely and Image Gently campaigns, as well as the national effort,聽which seeks to educate patients and doctors about unnecessary tests such as or back pain.

A “decision support” system that creates a set of standards for doctors to follow, pioneered at Massachusetts General Hospital in Boston, reduced the rate of inappropriate imaging tests from 6 percent in 2006 to 1.5 percent in 2014, said James Brink, the hospital’s radiologist-in-chief. A similar statewide program in Minnesota cut the growth rate from 7 percent per year to about 1 percent annually.

New 聽will require doctors to consider appropriateness criteria developed by the聽American College of Radiology when ordering imaging. Beginning this year, Medicare will reduce by 5 percent reimbursement for CT scans performed on machines that fail to meet modern standards, including the ability to automatically adjust radiation doses.

But significantly reducing the number of unnecessary CT scans may be an uphill battle.

A recent study found that doctors who order a lot of tests — a practice known as defensive medicine — get sued less often.

Some radiologists say they spend their days reading scans that trigger a cascade of follow-up tests and procedures for conditions that nearly always turn out to be benign. “I see two or three [incidentalomas] on every scan,” said , a radiologist at the VA Medical Center in West Haven, Connecticut, who teaches at the Yale School of Medicine. “I never see a normal patient.”

Financial incentives also fuel the casual use of scans. “Radiology has become an enormous profit” center for hospitals, Smith-Bindman said. “The amount we get paid is very high” under fee-for-service systems.

Patient demand is a key factor. Many people, unaware of the radiation risk, push for tests in the erroneous belief that they signify cutting-edge care. “If a patient requests [a CT scan] and a doctor says no, it could be a good starting point for a conversation,” said Orly Avitzur, medical director for Consumer Reports. But too often, doctors feel pressed for time so they just order the test. “As a practicing neurologist, I can tell you it is a very tough thing to say, ‘No, this is not needed at this time.’ “

To determine whether a CT is necessary, Avitzur said, patients should ask why the scan is being done, how the results might affect treatment and whether an alternative such as ultrasound or an MRI could be used instead.

How Much Is Too Much?

Among radiologists, the debate about the risk of cancer from diagnostic CTs rages.

“Everything we do in medicine involves trade-offs,” said Smith-Bindman, who directs UCSF’s Radiology Outcomes Research Lab. “The risks of radiation are real, and radiation leads to cancer. I think the data are quite compelling and not that hard to understand.”

But others disagree. “I don’t think the risks are as clear-cut” as Smith-Bindman contends, said Mass General’s Brink, vice chairman of the board of the American College of Radiology. In a he co-authored,聽Brink characterized the risk of cancer from diagnostic scans as “unproved” and “overemphasized,” based in part on uncertainty about the effect of radiation.

Scott Berger, director of neuroradiology at the Mount Kisco Medical Group in New York, agrees. “The risk of dying from a cancer that is not detected is thousands of times greater than” from radiation, he said. “These tests are lifesaving, they are great for patients.”

But Marta Hernanz-Schulman, medical director of radiology at the Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, is less gung-ho.

“Is radiation a real problem?” she asked. “We don’t know, but we need to act as if it were.” Studies performed in the United Kingdom 聽and Australia in聽 found an increase in cases of leukemia and malignant brain tumors among children and young adults who had undergone CT scans. One concern, said Hernanz-Schulman, a past president of the Society for Pediatric Radiology, is that many children undergo CT scans in adult facilities and may receive excessive doses because scanners are not adjusted聽between patients.

At Vanderbilt, children brought to the ER after a motor vehicle accident used to automatically get an abdominal CT scan. “Now we get liver enzymes first to see if they have a liver [injury] and we need a CT scan,” she said. In the past decade the number of CT scans has been cut by nearly half, she said.

Smith-Bindman said that excessively high radiation dosage is a problem requiring urgent attention. A 2009 study she led found that the actual radiation doses from CT scans varied as much as 聽for the same test performed at the same hospital, and these doses were much higher than those required to make a diagnosis. Except for mammography, there are no federal regulations governing radiation doses.

There are several reasons for the variation, Smith-Bindman said, including the failure to adjust the radiation dose based on body size and a desire to achieve more finely detailed images, which can be achieved by ramping up the dose. Nor are there national standards for technologists who administer CT scans, which involve increasingly sophisticated equipment. Some states don’t even require that they be licensed, allowing virtually anyone to operate the equipment.

“There’s no standardization of how these exams get conducted,” Smith-Bindman said. “There’s no oversight and no one’s responsible for this.”

Recently, she said, she spoke to a group of 300 radiology technologists and was “dumbfounded” by their questions. One asked her, “How do I pick a dose?” The technologist said she had devised her facility’s CT protocol, a job that is supposed to be performed by radiologists. Another said that in her hospital, “no one cares” about radiation doses.

Test Declined

Although Jean Hanvik avoided an abdominal CT after her diverticulitis flared, a few months later she had a different experience with a painful wrist. Before an orthopedist would see her, he required that she get an MRI scan, much of which she had to pay for out of pocket. It revealed that she had arthritis. Hanvik wonders why an expensive scan was necessary, particularly before ever talking to the doctor.

“I’m frustrated that diagnostic imaging has become the first line of defense,” she said. “I’m learning to ask a lot more questions.”

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Diagnosed with prostate cancer at age 60, Hart had undergone virtually every treatment 鈥� surgery, radiation and hormones 鈥� to eradicate it. But a blood test showed that his level of prostate-specific antigen, which should have been undetectable, kept rising ominously. And doctors couldn’t determine where the residual cancer was lurking.

“I didn’t like the sound of that,” said Hart, a retired international oil specialist for the federal government. “I wanted it gone,” he added, especially after learning that he had inherited the , making him vulnerable to other cancers.

So when Andrew Joel, Hart’s longtime urologist at in Arlington, mentioned the hospital’s membership in the and suggested consulting specialists at the Rochester, Minn., hospital for a second opinion, Hart enthusiastically agreed.

A Mayo immunologist told Joel about a , not then available in the Washington area, that can detect tiny cancer hot spots. Hart flew to Mayo for the scan, which found cancer cells in one lymph node in his pelvis. He underwent chemotherapy at Virginia Hospital Center and five weeks of radiation at the Mayo Clinic. Since September 2016, there has been no detectable cancer.

“This collaboration was sort of a magic process,” Hart said. “I feel very fortunate.”

‘Benefit By Association’

Hart’s experience showcases the promise of a much-touted but little understood collaboration in health care: alliances between community hospitals and some of the nation’s biggest and most respected institutions.

For prospective patients, it can be hard to assess what these relationships actually mean 鈥� and whether they matter.

Leah Binder, president and chief executive of , a Washington-based patient safety organization that grades hospitals based on data involving medical errors and best practices, cautions that affiliation with a famous name is not a guarantee of quality.

“Brand names don’t always signify the highest quality of care,” she said. “And hospitals are really complicated places.”

Affiliation agreements are “essentially benefit by association,” said Gerard Anderson, a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. “In some cases it’s purely branding and in other cases it’s a deep association.”

A key question is “how often does the community hospital interact with the flagship hospital? If it’s once a week, that’s one thing. If it’s almost never, that’s another,” Anderson said.

Feeling ‘Plugged In’

To expand their reach, flagship hospitals including Mayo, and Houston’s have signed affiliation agreements with smaller hospitals around the country. These agreements, which can involve different levels of clinical integration, typically grant community hospitals access to experts and specialized services at the larger hospitals while allowing them to remain independently owned and operated. For community hospitals, a primary goal of the brand-name affiliation is stemming the loss of patients to local competitors.

In return, large hospitals receive new sources of patients for clinical trials and for the highly specialized services that distinguish these “destination medicine” sites. Affiliations also boost their name recognition 鈥� all without having to establish a physical presence.

In some cases, large hospital systems opt for a different approach, largely involving acquisition. Johns Hopkins and Suburban hospitals in the Washington, D.C., area, along with All Children’s Hospital in St. Petersburg, Fla. The latter was re-christened Johns Hopkins All Children’s Hospital in 2016.

New York’s Memorial Sloan Kettering Cancer Center has embraced a hybrid strategy. It operates a surrounding Manhattan and has with three partners in Connecticut, Pennsylvania and Florida.

“Every one of these models is different,” said Ben Umansky, managing director for research at the Advisory Board, a Washington-based consulting firm.

Local hospitals, he said, particularly those operating “in the shadows of giants,” may be better able to retain patients “by getting a name brand on their door. … There is a sense that they are plugged in.” (Virginia Hospital Center, for example, competes with Hopkins, MedStar Washington Hospital Center, which has an alliance with the Cleveland Clinic, and the Northern Virginia-based Inova system.)

Doctors can obtain speedy second opinions for their patients and streamline visits for those with complex or unusual medical needs, processes that can be daunting and difficult without connections.

Dr. Michael Kupferman, senior vice president of the MD Anderson Cancer Network, said it seeks to “elevate the quality of cancer care” by forming partnerships with “high-quality [hospitals] to keep patients at home and provide the imprimatur of MD Anderson.”

Virginia Hospital Center’s association with Mayo is “not just a branding affiliation, it’s a deep clinical affiliation,” said Dr. Jeffrey DiLisi, senior vice president and chief medical officer at the Arlington facility.

Despite extensive marketing, many patients seem unaware of the linkage. “We still think a lot about ‘How do we communicate this?'” DiLisi said.

Although affiliation agreements differ, many involve payment of an annual fee by smaller hospitals. Officials at Mayo and MD Anderson declined to reveal the amount, as did executives at several affiliates. Contracts with Mayo must be renewed annually, while some with MD Anderson exceed five years.

Acceptance is preceded by site visits and vetting of the community hospitals’ staff and operations. Strict guidelines control use of the flagship name.

“It is not the Mayo Clinic,” said Dr. David Hayes, medical director of the Mayo Clinic Care Network, which was launched in 2011. “It is a Mayo clinic affiliate.”

Of the 250 U.S. hospitals or health systems that have expressed serious interest in joining Mayo’s network, 34 have become members.

For patients considering a hospital that has such an affiliation, Binder advises checking ratings from a variety of sources, among them Leapfrog, and , and not just relying on reputation.

“In theory, it can be very helpful,” Binder said of such alliances. “The problem is that theory and reality don’t always come together in health care.”

Case in point: Hopkins’ All Children’s has been聽 of catastrophic surgical injuries and errors and a spike in deaths among pediatric heart patients since Hopkins took over. Hopkins’ chief executive has apologized, more than a half-dozen and Hopkins recently to conduct a review of what went wrong.

“For me and my family, I always look at the data,” Binder said. “Nothing else matters if you’re not taken care of in a hospital, or you have the best surgeon in the world and die from an infection.”

Cancer During Pregnancy

Bryan Mills, chief executive of , was unhappy with his oncology service. Specialists at the Indianapolis-area hospitals he headed were competing against each other and patients were being ill-served. So Mills cold-called MD Anderson and, in 2012, Community joined its network.

“We needed something we could rally around,” Mills said.

“This is really not about a competitive advantage to me, but about providing optimal care,” said Mills, whose network competes with three other systems including one run by the University of Indiana, which operates a .

“One hundred percent of the work we do is audited by MD Anderson,” Mills said. “We can get second opinions almost instantly.”

Mills said he believes that the affiliation, which is prominently displayed on Community’s website, has attracted patients. In 2012, he said, Community treated about 2,000 cancer patients. In 2018, the number was 5,000.

Among them is Kamaljit “Kelly” Kaur. Shortly before Christmas 2015 the Greenwood, Ind., licensed practical nurse was diagnosed with , a rare and aggressive form of the disease usually discovered at an advanced stage. At the time, Kaur was 35 and five months pregnant with her third child.

Kaur said that her Indiana doctors conferred with MD Anderson oncologists and used “their guidelines to treat me. I felt comforted by that, like it was the right choice for me.” Her biggest concern, she said, was the health of her baby.

During the final months of her pregnancy, Kaur received weekly chemotherapy. Her son was born healthy and at full term in February 2016. She then underwent a bilateral mastectomy, followed by more chemo and radiation. Kaur said she has been cancer-free since January 2017, when she finished treatment. The collaboration, she said, “helped me get through this.”

Kaur’s Indiana oncologist, Dr. Anuj Agarwala, said he thought the MD Anderson involvement was helpful, because it reassured Kaur and him by concurring with his recommendations. He said he presented his treatment plan to specialists in Houston and “they didn’t change anything.”

Overall, he said, “it really doesn’t affect what I do very much. We are following national guidelines and not giving off-the-wall treatment.”

Initially, Agarwala said, some Community oncologists bristled at having their charts audited by Houston specialists, a resistance he said has diminished.

The affiliation has strengthened safety measures involving the administration of chemotherapy and has made the informed consent process more rigorous, Agarwala said, to the benefit of patients. “Overall it has been a valuable relationship.”

“The population I work with don’t have the resources to get care outside of their hometown,” he added, “and feel more confident with the input of a world-class institution.”

So did Dr. James Ouellette, a cancer surgeon with Premier Health in Dayton, Ohio, which joined the MD Anderson network in 2016.

In November 2018, Ouellette removed a huge and rare malignant tumor from Joanne Dotson’s abdomen during a four-hour surgery. The solitary fibrous tumor was in a dicey location: It had grown so large it was displacing Dotson’s liver and compressing her vena cava, a major vein that carries blood to the heart.

Dotson, 70, said she had never heard of MD Anderson until her doctors mentioned it.

The affiliation, she said, did not affect her choice of hospital or surgeon, in whom she had confidence.

“I wasn’t even worried,” she said. “His hands are God’s hands,” she said, referring to Ouellette.

Her surgeon felt differently.

“While I was very glad Mrs. Dotson wasn’t worried, I was, with a big surgery like that,” Ouellette said. Before the operation, Ouellette said he conferred with an MD Anderson surgeon, radiation oncologist and medical oncologist about how best to treat the grapefruit-size growth. As a result of those discussions, Ouellette said, he altered the initial treatment plan.

Getting A Vibe

Virginia Hospital Center officials say that only a handful of the approximately 170 patients, the vast majority with cancer diagnoses, who annually receive second opinions from Mayo wind up getting treatment there. Most of those who do, DiLisi said, received care unavailable at his hospital.

“The patients [that affiliates] send us are more complex patients,” said Mayo’s Hayes. “We have a broad and deep bench of specialists.”

Even so, it’s often doctors who suggest a second opinion, not patients who request one. Joel said he mentions the option to those urology patients from whom he gets “a vibe” that they might be interested.

DiLisi said that the affiliation can save patients time and money.

“We get them as good a second opinion as they would get at Hopkins,” DiLisi said, without incurring the costs and additional testing involved. “And they don’t have to drive to Baltimore.”

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Since his graduation last year from the University of San Diego, Brown has held a series of jobs that have taken him to several California cities. “As a young person in a nomadic state,” Brown said, he prefers finding a walk-in clinic on the rare occasions when he’s sick.

“The whole ‘going to the doctor’ phenomenon is something that’s fading away from our generation,” said Brown, who now lives in Daly City outside San Francisco. “It means getting in a car [and] going to a waiting room.” In his view, urgent care, which costs him about $40 per visit, is more convenient聽鈥� “like speed dating. Services are rendered in a quick manner.”

Brown’s views appear to be shared by many millennials, the 83 million Americans born between 1981 and 1996 who constitute the nation’s biggest generation. Their preferences 鈥� for convenience, fast service, connectivity and price transparency 鈥� are upending the time-honored model of office-based primary care.

Many young adults are turning to a fast-growing constellation of alternatives: retail clinics carved out of drugstores or big-box retail outlets, free-standing urgent care centers that tout evening and weekend hours, and online telemedicine sites that offer virtual visits without having to leave home. Unlike doctors’ offices, where charges are often opaque and disclosed only after services are rendered, many clinics and telemedicine sites post their prices.

A of 1,200 randomly selected adults conducted in July by the Kaiser Family Foundation for this story found that 26 percent said they did not have a primary care provider. There was a pronounced difference among age groups: 45 percent of 18- to 29-year-olds had no primary care provider, compared with 28 percent of those 30 to 49, 18 percent of those 50 to 64 and 12 percent age 65 and older. (Kaiser Health News is an editorially independent program of the foundation.)

A by the Employee Benefit Research Institute, a Washington think tank, and Greenwald and Associates yielded similar results: 33 percent of millennials did not have a regular doctor, compared with 15 percent of those age 50 to 64.

“There is a generational shift,” said Dr.聽, an internist and associate professor in the Department of Health Care Policy at Harvard Medical School. “These trends are more evident among millennials, but not unique to them. I think people’s expectations have changed. Convenience [is prized] in almost every aspect of our lives,” from shopping to online banking.

So is speed. Younger patients, Mehrotra noted, are unwilling to wait a few days to see a doctor for an acute problem, a situation that used to be routine. “Now,” Mehrotra said, “people say, ‘That’s crazy, why would I wait that long?'”

Until recently, the after-hours alternative to a doctor’s office for treatment of a strep throat or other acute problem was a hospital emergency room, which usually meant a long wait and a big bill.

Luring Millennials

For decades, primary care physicians have been the doctors with whom patients had the closest relationship, a bond that can last years. An internist, family physician, geriatrician or general practitioner traditionally served as a trusted adviser who coordinated care, ordered tests, helped sort out treatment options and made referrals to specialists.

But some experts warn that moving away from a one-on-one relationship may be and worsening the problem of fragmented or unnecessary care, including the misuse of antibiotics.

A recent report in JAMA Internal Medicine found that nearly half of patients who sought treatment at an urgent care clinic for a cold, the flu or a similar respiratory ailment left with an unnecessary and potentially harmful prescription for antibiotics, compared with 17 percent of those seen in a doctor’s office. Antibiotics are useless against viruses and may expose patients to severe side effects with just a single dose.

“I’ve seen many people who go to five different places to be treated for a UTI [urinary tract infection] who don’t have a UTI,” said Dr. Janis Orlowski, a nephrologist who is chief health care officer at the Association of American Medical Colleges, or AAMC. “That’s where I see the problem of not having some kind of continuous care.”

“We all need care that is coordinated and longitudinal,” said Dr. Michael Munger, president of the American Academy of Family Physicians, who practices in Overland Park, Kan. “Regardless of how healthy you are, you need someone who knows you.” The best time to find that person, Munger and others say, is before a health crisis, not during one.

And that may mean waiting weeks. A by physician search firm Merritt Hawkins found that the average wait time for a new-patient appointment with a primary care doctor in 15 large metropolitan areas is 24 days, up from 18.5 days in 2014.

While wait times for new patients may reflect a聽 鈥� in the view of the AAMC 鈥� or a , as other experts argue, there is no dispute that primary care alternatives have exploded. There are now more than in the United States, most in the South and Midwest, according to Rand Corp. researchers.

Connecting With Care

To attract and retain patients, especially young adults, primary care practices are embracing new ways of doing business.

Many are hiring additional physicians and nurse practitioners to see patients more quickly. They have rolled out patient portals and other digital tools that enable people to communicate with their doctors and make appointments via their smartphones. Some are exploring the use of video visits.

Mott Blair, a family physician in Wallace, N.C., a rural community 35 miles north of Wilmington, said he and his partners have made changes to accommodate millennials, who make up a third of their practice.

“We do far more messaging and interaction through electronic interface,” he said. “I think millennials expect that kind of connectivity.” Blair said his practice has also added same-day appointments.

Although walk-in clinics may be fine as an option for some illnesses, few are equipped to provide holistic care, offer knowledgeable referrals to specialists or help patients decide whether they really need, say, knee surgery, he noted. Primary care doctors “treat the whole patient. We’re tracking things like: Did you get your mammogram? Flu shot? Pap smear? Eye exam?”

Dr. Nitin Damle, an internist and past president of the American College of Physicians, said that young people develop diabetes, hypertension and other problems “that require more than one visit.”

“We know who the best and most appropriate specialists in the area are,” said Damle, an associate clinical professor of medicine at Brown University in Providence, R.I. “We know who to go to for asthma, allergies, inflammatory bowel disease.”

Marquenttha Purvis, 38, said her primary care doctor was instrumental in helping arrange treatment for her stage 2 breast cancer last year. “It was important because I wouldn’t have been able to get the care I needed” without him, said Purvis, who lives in Richmond, Va.

Sometimes the fragmented care that can result from not having a doctor has serious consequences.

Orlowski cites the case of a relative, a 40-year-old corporate executive with excellent medical insurance. The man had always been healthy and didn’t think he needed a primary care physician.

“Between treating himself and then going to outpatient clinics,” he spent nearly a year battling a sore throat that turned out to be advanced throat cancer, she said.

For patients without symptoms or a chronic condition such as asthma or high blood pressure, a yearly visit to a primary care doctor may not be necessary. Experts no longer recommend the for people of all ages.

“Not all access has to be with you sitting on an exam table,” Munger said. “And I may not need to see you more than every three years. But I should be that first point of contact.”

Convenience Is Paramount

Caitlin Jozefcyk, 30, a high school history teacher in Sparta, N.J., uses urgent care when she’s sick. She dumped her primary care doctor seven years ago because “getting an appointment was so difficult” and he routinely ran 45 minutes behind schedule. During her recent pregnancy, she saw her obstetrician.

Jozefcyk knows she’s not building a relationship with a physician 鈥� she sees different doctors at the center聽鈥� but “really likes the convenience” and extended hours.

Digital access is also important to her. “I can make appointments directly through an app, and prescriptions are sent directly to the pharmacy,” she said.

After years of going to an urgent care center or, when necessary, an emergency room, Jessica Luoma, a 29-year-old stay-at-home mother in San Francisco, recently decided to find a primary care doctor.

“I’m very healthy, very active,” said Luoma, who has been treated for a kidney infection and a miscarriage.

Luoma said her husband pushed her to find a doctor after the insurance offered by his new employer kicked in.

“He’s a little more ‘safety first’ than me,” she said. “I figured, ‘Why not?’ 鈥� just in case.”

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Devitt’s white blood cell count and several other tests were flagged as abnormal. Beyond the raw numbers, there was no explanation.

“I got really tense and concerned,” said Devitt, 39, a manager of data analysis who lives in New Orleans. She immediately began searching online and discovered that possible causes ranged from a trivial infection to cancer.

“I was able to calm myself down,” said Devitt, who waited anxiously for her doctor to call. Two days later, after hearing nothing, she called the office. Her doctor telephoned the next day. She reassured Devitt that the probable cause was her 5-year-old’s recent case of pinkeye and advised her to get tested again. She did, and the results were normal.

“I think getting [test results] online is great,” said Devitt, who says she wishes she had been spared days of needless worry waiting for her doctor’s explanation. “But if it’s concerning, there should be some sort of note from a doctor.”

Devitt’s experience illustrates both the promise and the perils of a largely unexamined transformation in the way growing numbers of Americans receive sensitive 鈥� sometimes life-changing 鈥� medical information. A decade ago, most patients were informed over the phone or in person by the doctor who had ordered testing and could explain the results.

But in the past few years, hospitals and medical practices have urged patients to sign up for portals, which allow them rapid, round-the-clock access to their records. Lab tests (with few exceptions) are now released directly to patients. Studies estimate that between 15 and 30 percent of patients use portals.

The push for portals has been fueled by several factors: the widespread embrace of technology, incentive payments to medical practices and hospitals that were part of 2009 federal legislation to encourage “” of electronic records, and a giving patients direct access to their results. Policymakers have long regarded electronic medical records as a way to foster patient engagement and improve patient safety. Studies have found that of abnormal lab results were not communicated to patients promptly.

Are portals delivering on their promise to engage patients? Or are these results too often a source of confusion and alarm for patients and the cause of more work for doctors because information is provided without adequate 鈥� or sometimes any 鈥� guidance?

Releasing results on portals remains “an answer with many questions,” said Hardeep Singh, a patient safety researcher at the Michael E. DeBakey VA Medical Center in Houston. “There is just not enough information about how it should be done right,” said Singh, who is also an associate professor at Baylor College of Medicine and one of the few researchers to study patients’ experiences obtaining test results from portals. “There are unintended consequences for not thinking it through.”

Although what patients see online and how quickly they see it differs 鈥� sometimes even within the same hospital system 鈥� most portals contain lab tests, imaging studies, pathology reports and less frequently, doctors’ notes. It is not uncommon for a test result to be posted before the doctor has seen it.

That means that a patient may be the first to learn of a suspicious breast mass, a recurrence of cancer or possible kidney failure. At Johns Hopkins medical system in Baltimore, for example, results of a PSA test to screen for prostate cancer come with this disclaimer: “While Johns Hopkins providers check results frequently, you may see results before your provider has seen them.”

Breast cancer specialist Lidia Schapira is an associate professor at the Stanford University Medical Center and editor-in-chief of Cancer.net, the patient information website of the American Society of Clinical Oncology. While she regards online access as beneficial, “the danger is that the patient may learn information they’re unprepared to receive and may feel abandoned if they can’t reach their doctor.”

“Those are the Friday afternoon phone calls,” she said, when “at 4:59 [p.m.] a patient has accessed the results of a scan and the doctor signs out at 5.” The recipient of the anguished inquiry that follows is typically a covering doctor who doesn’t know the patient or details of the case.

When Is Use Meaningful?

A by Singh and his colleagues found that, like Devitt, nearly two-thirds of 95 patients who obtained test results via a portal received no explanatory information about the findings. As a result, nearly half conducted online searches. Many with abnormal results called their doctors.

That echoes a led by researchers from the University of Pittsburgh. These scientists found that in addition to engaging patients, portal use may increase anxiety and lead to more doctor visits.

Among patients with low health literacy and numerical skills, confusion about the meaning of results is common. Many tests are reported in the same form that the doctor sees them, which even savvy patients may find “literally meaningless,” observed Brian Zikmund-Fisher, an associate professor in the school of public health at the University of Michigan.

“In some situations we run the risk of patients misinterpreting that there is no problem when there is one, or assuming there’s a problem when there isn’t,” said Zikmund-Fisher, lead author of a study that advocates the use of to convey results. “What we need to be focusing on is giving patients context.”

A year or so ago, Geisinger Health System in Pennsylvania began making most test results 鈥� but not biopsies or HIV screening 鈥� available to patients within four hours of being finalized.

“We essentially release results twice a day seven days a week with a four-hour lag,” said Ben Hohmuth, Geisinger’s associate chief medical informatics officer. The delay, he said, gives doctors time to review results. Patients who log on over a weekend can contact an on-call physician if they can’t reach their own doctor. The goal of rapid release, Hohmuth said, is to “be patient-centered and transparent.”

“The majority [of patients] want early access to their results, and they don’t want it to be impeded” while waiting for doctors to contact them, Hohmuth said, even if the news is bad.

Patient reaction, he adds, has been “overwhelmingly positive”; the few complaints have come from physicians.

Health lawyer Kathleen Kenyon said she would have appreciated faster access to blood test results for her elderly mother, who had multiple medical problems including Alzheimer’s disease. Kenyon, who managed and closely monitored her mother’s condition, said she believes speedier access could have helped stave off a four-day hospitalization in the intensive care unit of a Washington hospital caused by her mother’s plummeting sodium level.

“It is safer for patients to have more information,” said Kenyon, formerly a senior policy analyst at the Department of Health and Human Services. “I was begging them to get my mother’s lab information in earlier.”

What Does This Mean?

At 46, writer Rebecca Esparza has survived Stage 4 ovarian cancer as well as thyroid cancer. She normally loves having round-the-clock access to her records and the ability to email her doctors.

But in 2016, immediately after extensive abdominal surgery at a hospital several hours from her home in Corpus Christi, Texas, doctors told her they suspected she had developed colon cancer. Confirmation would require further evaluation by a pathologist.

Esparza went home and waited, checking her portal repeatedly. A week later, she logged on to find a highly technical biopsy report she could not understand. A friend who is a nurse read it and told Esparza there was no mention of a malignancy. Two weeks after Esparaza left the hospital and a week after the report appeared on her portal, one of her doctors confirmed that she didn’t have cancer after all.

“It was really traumatic and the one time I wish I hadn’t had access,” said Esparza, an advocate for the National Coalition for Cancer Survivorship.

Although Esparza considers her experience to be “a fluke,” she notes similar confusion among other cancer patients in the online support groups she runs.

“People post their blood test and other results all the time and ask what it means,” she said. Esparza said she intercedes by reminding participants “we’re not doctors.”

One way for a physician to provide guidance, said Stanford’s Schapira, is for doctors to negotiate with patients in advance, particularly if they are concerned the news might be bad.

It is a strategy she employed at her previous job at Massachusetts General Hospital in Boston. “I would say, ‘Let’s do a scan and then schedule a visit two days later, and we can discuss the results,'” she said.

One Doctor’s Experience

Mass General internist Katharine Treadway knows what it’s like to obtain shocking news from an electronic medical record. The experience, she said, has influenced the way she practices.

More than a decade ago 鈥� long before most patients had portals 鈥� Treadway, with her husband’s permission, pulled up the results of his MRI scan on a hospital computer while waiting to see the specialist treating his sudden, searing arm pain.

“It showed a massive tumor” and widespread metastatic disease, Treadway recalled. She never suspected that her 59-year-old husband had cancer, let alone a highly aggressive and usually fatal form of advanced lymphoma.

Treadway said she remembers intently checking the name and date of birth, certain she had the wrong patient, then rebooting the computer several times “like I was going to get a different answer.”

“The difference is that I knew exactly who to call and what to do,” said Treadway, whose for more than a decade. “In the event of bad news, a doctor has to surround the patient with ‘I am here for you and here’s the plan.'”

Schapira agrees. “Clinicians have to start tackling the issues that have arisen as a result of instant access,” she said.

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For decades, experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons. Researchers 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions, a figure that jumps to nearly 46 percent for those between 70 and 79. Doctors say it is not uncommon to encounter patients taking more than 20 drugs to treat acid reflux, heart disease, depression or insomnia or other disorders.

Unlike the overuse of opioid painkillers, the polypharmacy problem has attracted little attention, even though its hazards are well documented. But some doctors are working to reverse the trend.

At least 15 percent of seniors seeking care annually from doctors or hospitals have suffered a medication problem; in half of these cases, the problem is believed to be potentially preventable. Studies have linked polypharmacy to . Older patients, who have greater difficulty metabolizing medicines, are more likely to suffer dizziness, confusion and falls. And the side effects of drugs are frequently misinterpreted as a new problem, triggering more prescriptions, a process known as a .

The glide path to overuse can be gradual: A patient taking a drug to lower blood pressure develops swollen ankles, so a doctor聽prescribes a diuretic. The diuretic causes a potassium deficiency, resulting in a medicine to treat low potassium. But that聽triggers nausea, which is treated with another drug, which causes confusion, which in turn is treated with more medication.

For many patients, problems arise when they are discharged from the hospital on a host of new medications, layered on top聽of old ones.

Alice Cave, who divides her time between Alexandria, Va., and Tucson, Ariz., discovered this when she traveled to Cheyenne, Wyo., after her 87-year-old aunt was sent home following treatment for a stroke in 2015.

Before her hospitalization, Cave said, her aunt, a retired telephone company employee whose vision is impaired by glaucoma, had been taking seven drugs per day. Five new ones were added in the hospital, Cave said.

“She came home and had a huge bag of pills, half of which she was already taking, plus pages and pages of instructions,” she聽said. Some were supposed to be taken with food, some on an empty stomach. Cave said she spent several hours sorting the medications聽into a giant blue pill box. “It was crazy — and scary.”

Cave said she felt helpless to do much; her aunt’s doctors didn’t question the need for more drugs.

When Shannon Brownlee’s mother was taken to an emergency room recently to determine whether her arm pain might signal a heart attack (it didn’t) a cardiologist prescribed five new drugs — including an opioid — to the small dose of a diuretic she had been taking to control her blood pressure.

Brownlee, senior vice president of the , a Boston-based group that seeks to improve health care quality by reducing unnecessary treatment, said that when her brother questioned the necessity of so many new drugs for a woman in her late 80s, the specialist replied frostily, “I don’t see anything wrong with prescribing lots of medication to older people.”

Bring The Pill Bottles

“This problem has gotten worse because the average American is on a lot more medications than 15 years ago,” said cardiologist Rita Redberg, a professor of medicine at the University of California at San Francisco.

Studies bolster Redberg’s contention: A found that the share of Americans of all ages who regularly took at least five prescription drugs nearly doubled between 2000 and 2012, from 8 percent to 15 percent. University of Michigan researchers recently reported that the percentage of people older than 65 taking at least three psychiatric drugs in the nine years beginning in 2004. Nearly half of those taking the potent medications, which include antipsychotic drugs used to treat schizophrenia, had no mental health diagnosis.

Redberg and other doctors are trying to counter the blizzard of prescriptions through a grass-roots movement called “” —聽systematically discontinuing medicines that are inappropriate, duplicative or unnecessary.

Interest in deprescribing, which was pioneered in Canada and , is growing in the United States, bolstered by physician-led聽efforts, such as the five-year-old campaign. The , a list of overused and potentially unsafe drugs for seniors first published in 1991, has been followed by aimed at curbing unnecessary drug use.

“Lots of different medications get started for reasons that are never supported by evidence,” said Redberg, editor in chief of JAMA Internal Medicine. “In general, we like the idea of taking a pill” a lot better than non-drug measures, such as improved eating habits or exercise.

“That’s what we were taught as physicians: to prescribe drugs,” said Ranit Mishori, a professor of family medicine at Georgetown University and a . “We are definitely not taught how to take people off meds.”

Kathryn McGrath, a Philadelphia geriatrician, said she tries to begin every appointment with a review of medications, which she asks patients to bring with them. “I think having the pill bottles” is much more powerful than a list, said McGrath, who has written about safely.

Although support is growing, deprescribing faces formidable obstacles.

Among them, experts say, is a paucity of research about how best to do it, relentless advertising that encourages consumers to ask their doctors for new drugs, and a strong disinclination – baked into the culture of medicine — to countermand what another physician has ordered. Time constraints play a significant role. So do performance measures that are viewed as a mandate to prescribe drugs even when they make virtually no sense, such as giving statins to terminally ill patients.

A Reluctance To Overrule

“There’s a reluctance to tinker or change things too much,” said University of Michigan geriatric psychiatrist Donovan Maust, who labels the phenomenon “clinical inertia.” When inheriting a new patient, Maust said, doctors tend to assume that if a colleague prescribed a drug, there must be a good reason for it — even if they don’t know what it is. Maust said he tries to combat inertia by writing time-limited orders for medication.

He recently began treating a man in his 80s with dementia who was taking eight psychiatric drugs — each of which can cause significant side effects and most of which had been prescribed for undetermined reasons.

“It’s very typical to see a patient who has a few episodes of reflux and is then put on a [proton pump inhibitor, or PPI] and a few years later are still taking it,” said Georgetown’s Mishori. Many experts say the heartburn drugs , and studies have to fractures, dementia and premature death.

“This is a cultural problem and an awareness problem exacerbated by the fragmentation of care,” said Brownlee, the author of “.” Many doctors, she added, have never heard of deprescribing.

Before his death several years ago, doctors advised Brownlee’s father, a hospice patient, to continue taking a statin, along with several other medications. None would improve or extend his life, and all had potentially harmful side effects.

Rx: What For?

Older people taking lots of medication was what Canadian pharmacist Barbara Farrell encountered when she began working at a geriatric hospital in Ottawa nearly two decades ago. Her experience, she said, was a catalyst for the Canadian Deprescribing Network, a consortium of researchers, physicians, pharmacists and health advocates she co-founded. The group seeks to drastically reduce inappropriate medication use among Canadian seniors by 2020.

Farrell, a clinical scientist at the Bruyere Research Institute, has also helped , used by doctors in the United States and other countries, to safely deprescribe certain classes of widely used drugs, including proton pump inhibitors and sedatives.

“I’ve found a lot of receptivity” to the guidelines among physicians, Farrell said. “We know there are pockets around Canada and the world where they’re being implemented.”

One of Farrell’s most memorable successes involved a woman in her late 70s who was using a wheelchair and was nearly comatose.

“She would literally slide out of her chair,” Farrell recalled. The woman was taking 27 drugs four times per day and had been diagnosed with dementia and a host of other ailments.

After reviewing her medications, Farrell and her colleagues were able to weed out duplicative and potentially harmful drugs and reduce the doses of others. A year later, the woman was “like a different person”: She was able to walk with a cane and live mostly independently, and she reported that her doctor said she did not have dementia after all.

When Farrell asked another patient why she was taking thyroid medication, the woman replied that her doctor had prescribed it for weight loss after her last pregnancy — in 1955.

“The patients I see are the tip of the iceberg,” Farrell said.

One way to facilitate deprescribing, Farrell said, is to require doctors to record why a drug is being prescribed, a proposal the deprescribing network has made to Canadian health officials. A by a team from the Boston VA Healthcare System found strong support among doctors for this concept.

While some doctors are reluctant to discontinue medications, patients can be wary, too.

“They may say, ‘I tried stopping my sleeping pill and I couldn’t sleep the next night, so I figured I needed it,'” Farrell said. ” Nobody explained to them that , which can occur after stopping sleeping pills, lasts three to five days.”

Mishori said that she deprescribes only one medication at a time so she can detect any problem that arises from that change. And, she adds, “I never take people off of a medication without doing something else.” In the case of heartburn drugs, she might first recommend taking the drug only when needed, not continuously. Or she might suggest a safer alternative, such as an over-the-counter antacid tablet.

Maust, the geriatric psychiatrist, recommends that doctors actively focus on “the big picture” and carefully weigh whether the benefits of a drug outweigh its risks.

“In geriatrics,” he said, “less is more.”

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But over the past two years, the issue of overlapping surgery 鈥� in which a doctor operates on two patients in different rooms during the same time period 鈥� has ignited an impassioned debate in the medical community, attracted聽聽by the powerful Senate Finance Committee that oversees Medicare and Medicaid, and prompted some hospitals, including the University of Virginia’s, to circumscribe the practice.

Known as “running two rooms” 鈥� or double-booked, simultaneous or concurrent surgery 鈥� the practice occurs in teaching hospitals where senior attending surgeons delegate trainees 鈥� usually residents or fellows 鈥� to perform parts of one surgery while the attending surgeon works on a second patient in another operating room. Sometimes senior surgeons aren’t even in the OR and are seeing patients elsewhere.

Hospitals decide whether to allow the practice and are primarily responsible for policing it. Medicare billing rules permit it as long as the attending surgeon is present during the critical portion of each operation 鈥� and that portion is defined by the surgeon. And while it occurs in many specialties, double-booking is believed to be most common in orthopedics, cardiac surgery and neurosurgery.

The issue was catapulted into public consciousness in October 2015 by an exhaustive聽聽of concurrent surgery at Harvard’s famed Massachusetts General Hospital by The Boston Globe. The validity of the story has been vehemently聽by hospital officials who defend their care as safe and appropriate.

The article detailed concerns by some doctors and other hospital staff about complications 鈥� including one patient who was paralyzed and two who died 鈥� possibly linked to double-booking over a 10-year period. It described patients waiting under anesthesia for prolonged periods and surgeons who could not be located, leaving residents or fellows to perform surgeries without supervision.

Patients who signed standard consent forms said they were not told their surgeries were double-booked; some said they would never have agreed had they known.

The practice has also figured prominently in cases in South Florida, Nashville and, most recently,聽

Critics of the practice, who include some surgeons and patient-safety advocates, say that double-booking adds unnecessary risk, erodes trust and primarily enriches specialists. Surgery, they say, is not piecework and cannot be scheduled like trains: Unexpected complications are not uncommon.

All patients “deserve the sole and undivided attention of the surgeon, and that trumps all other considerations,” said Michael Mulholland, chair of surgery at the University of Michigan Health System, which halted 颅double-booking a decade ago. Surgeons might leave the room when a patient’s incision is being closed, Mulholland said. A computerized system records the doctor’s entry and exit.

“It doesn’t do any good to check out your surgeon if they’re not even going to be in the room,” said Lisa McGiffert, director of Consumers Union’s聽. “We all know about the dangers of multitasking. This adds a layer of danger if you have the most expert person coming in and out.”

Indiana orthopedic surgeon James Rickert regards double-booking as a form of bait-and-switch. “The only reason it has continued is that patients are asleep,” said Rickert, president of the聽, a doctor group.

“Having a fellow so you can run two rooms helps augment your income,” he added. “You can bill for six procedures: You do three and the fellow does three.” The critical portion of the operation required by Medicare and designated by the surgeon can mean “running in and checking two screws for 10 seconds.”

Defenders of the practice, which has been the subject of a handful of studies with mixed results, say it can be done safely and allows more patients to receive care.

“It’s extremely important for us to make sure [all surgeries are] done with the highest quality,” said Peter Dunn, Mass General’s executive medical director of perioperative administration. Officials at his hospital, Dunn said in a recent interview, have “never traced back a quality issue” to concurrent surgery, which involves a minority of procedures.

Mass General complies with all applicable guidelines and regulations, Dunn said. The hospital now explicitly requires doctors to inform patients if an operation will overlap as part of the consent process, which may occur just before the start of surgery.

In January, a聽聽found that a Mass General spine surgeon who failed to inform a 45-year-old financial analyst that he was running two rooms was not responsible for the patient’s subsequent quadriplegia.

Divided Attention

No one knows how many of the nation’s 4,900 hospitals that receive Medicare payments 鈥� about 1,000 of which are teaching hospitals 鈥� allow the practice, the Senate Finance Committee noted in a recent report. The committee called on hospitals to adopt stronger policies and consent forms that go beyond opaque boilerplate statements that grant broad permission without specifying who is doing what. And the report noted that concurrent surgery may also occur in outpatient surgery centers and non-teaching hospitals and that it can involve patients who are not covered by Medicare.

The practice surprised some primary care doctors and a veteran medical ethicist.

“I certainly knew that for many procedures, residents might be involved,” said Arthur Caplan, a professor of bioethics at NYU School of Medicine. (NYU Langone Medical Center does not permit concurrent surgery.) “But I was a little taken aback that the attending surgeon was not in the room.”

Proponents say that overlapping operations can improve efficiency and better utilize a surgeon’s valuable time.

“Much of surgery is team-based,” said David Hoyt, executive director of the American College of Surgeons (ACS), which last year issued聽聽concurrent surgery. Largely similar to Medicare rules, the guidelines state that surgeons should inform patients of overlapping operations.

Robert Cima, a colorectal surgeon and medical director of surgical outcomes research at the Mayo Clinic, agrees. Overlapping surgery has been used safely since Mayo’s inception more than 100 years ago, he said.聽聽he co-authored found that 11,000 overlapping operations at Mayo did not have a higher death rate than non-overlapping surgeries.

Allowing qualified junior doctors to perform parts of an operation, Cima said, is vital in “training the next generation of surgeons.” Determining what portion of an operation is critical should be left to the individual surgeon, he said, not defined by Medicare or insurers, because it can vary from patient to patient.

But L.D. Britt, a past president of the ACS and chairman of surgery at Eastern Virginia Medical School in Norfolk, says that efficiency has little to do with concurrency. “Unless you’re closing, that surgeon should be there,” he said. “Most [surgeons] are doing it for lifestyle.”

Indiana’s Rickert and Britt say they are troubled by what they regard as a double standard: Very few surgeons would consent to the practice for themselves or a relative. “This happens to the Medicaid patient,” Rickert said, “not the partner’s wife.”

He advocates that Medicare and insurers define the critical portion requiring the presence of an attending surgeon as being everything between the making of an incision and the start of its closure, a task frequently performed by residents. “The critical components should not depend on whether the surgeon has opera tickets that night.”

Ghost Surgery?

Some surgeons say they are troubled by the resemblance of double-booking to a practice known as “” in which patients learn, usually after something goes wrong, that someone other than the surgeon they hired performed their operation.

In April, a Seattle jury awarded an anesthesiologist and her husband聽聽for botched abdominal surgery that disfigured his penis. After his operation, the couple discovered that a crucial part of the procedure was performed by a fellow, not the senior surgeon to whom he had explicitly granted consent.

“I always prided myself in telling patients I would be there from the moment they went to sleep to the moment they woke up,” said Stanley Shapshay, a head and neck surgeon in Albany, N.Y., who co-authored a 2016 editorial opposing simultaneous surgery.

Many things can go wrong during “noncritical” portions of an operation, particularly if a resident or fellow is unsupervised, said Shapshay, a professor of otolaryngology at Albany Medical College. A major artery or nerve can be cut accidentally, he said. “By the time the surgeon [arrives, the damage] has already been done.”

Trainees, Shapshay observed, vary. “Some are very good, some are OK and some need more experience.”

His view was reinforced by his experience at a hospital in the Southeast several years ago. A senior surgeon he was visiting left in the middle of an operation, after telling a family that surgery had gone well. While he and Shapshay were having coffee, the surgeon received an urgent page and had to rush back to the OR to deal with a serious breathing problem. The family was later told only that an unexpected event had occurred, not that the attending had been out of the room.

“That illustrated to me very clearly that you don’t leave the OR until the patient has left the OR,” Shapshay said.

Adequate informed consent is essential, said Robin Diamond, senior vice president for patient safety and risk management at the Doctors Company, a California-based malpractice insurer that has begun tracking malpractice claims related to overlapping surgery. She expects such lawsuits will increase.

“I think it can be done safely and has been safe in many cases,” said Diamond, who has degrees in nursing and law. But surgeons who plan to run two rooms should obtain explicit consent from patients at least a week ahead of surgery, she said, not the day before or the day of, as is common, to allow time to reconsider.

“It’s a basic patient right to know” who is doing their operation, Diamond said.

Patients don’t seem enamored of overlapping surgery. A聽by Harvard researchers found that fewer than 4 percent of 1,454 people had heard of concurrent surgery and that only 31 percent supported the practice; 95 percent said it should be disclosed in advance.

A Surprising Result

After the fallout at Mass General, officials at U.Va. decided it was time to largely eliminate concurrent surgery in all specialties; the practice had been most common in orthopedics.

In return for an end to simultaneous surgeries, hospital executives agreed that orthopedic surgeons would not be “disadvantaged,” said Richard Shannon, executive vice president for health affairs at U.Va. Part of the process involved overhauling the way surgeries were scheduled.

“It was an important wake-up call,” Shannon said of the controversy. “We wanted to redesign our system to eliminate the risk” as part of a larger聽.

Eliminating most concurrent procedures, Shannon said, actually resulted in an increase of 560 surgeries in 2016 over 2015, using the same number of operating rooms. “Concurrency was masking an efficiency problem,” said Shannon, who plans to publish the results of U.Va.’s efforts. “There was a lot of waste.”

“This debunks the urban legend” that overlapping surgery is more efficient, he said. “Like many things in health care, if you apply a rigorous disciplined approach, you may get an answer you didn’t expect.”

Rickert and others advise patients who want to avoid overlap to ask detailed questions well in advance and to put their request in writing and on the consent form.

“If you say, 鈥業 want only you to do the surgery,’ doctors will typically do it,’” Rickert said. “They want the business.”

He also recommends asking, “Are you going to be in the room the entire time during my surgery?” and then repeating that statement in front of the OR nurses the day of surgery. “If the doctor’s not willing to say yes, vote with your feet.”

If a surgeon says he or she will be “present” or “immediately available,” a patient should ask what that means. It may mean that the surgeon is somewhere on a sprawling hospital campus but not in 鈥� or even near 鈥� your operating room.

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Instead, Crisp spent weeks in a coma and underwent five surgeries to correct a near-fatal cascade of medical errors that left her with permanent injuries. Desperate for an explanation, Crisp, who is also a lawyer, said she repeatedly encountered a white wall of silence: The hospital and her surgeon refused to say little more than “things didn’t go well.” Crisp 聽piecing together what happened. “I decided I was going to find out even if it takes the rest of my life,” she said.

Jack Gentry said he “went into the hospital a patient and came out a victim.” In 2013, the retired Baltimore police officer suffered a catastrophic spinal cord injury during disk replacement surgery at MedStar Union Memorial Hospital that left him a quadriplegic.

But unlike Crisp, Gentry and his wife, a nurse, were immediately told what had gone wrong by his surgeon, who apologized for the error. The hospital covered Gentry’s rehabilitation and other major expenses and paid an undisclosed amount in compensation, all without litigation.

“When hospitals mess up, they need to do the right thing,” Gentry said. “MedStar did.”

For patients and their families killed or maimed by medical errors, Crisp’s experience 鈥� in which doctors clam up and hospitals deny wrongdoing and aggressively defend their care 鈥� remains standard operating procedure in most institutions.

But spurred by concerns about the “deny and defend” model 鈥� including its cost, lack of transparency and the perpetuation of errors 鈥� programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular. Researchers at Johns Hopkins University in Baltimore recently estimated that medical mistakes , which would make them the third-leading cause of death. Traditionally, the only way for patients to find out what went wrong has been to sue.

A blueprint for the approach used in Gentry’s case is being promoted by the federal Agency for Healthcare Research and Quality. Called , an acronym for Communication and Optimal Resolution, the approach is modeled on a long-standing program pioneered at the University of Michigan. It was tested in 14 hospitals around the country, including MedStar’s Washington Hospital Center and Georgetown University Hospital.

Although they differ, these programs 鈥� which typically feature prompt investigation of errors whose findings are shared with the victims, as well as an apology and compensation for injuries 鈥� are operating at the University of Illinois at Chicago, Stanford and and outpatient groups in Massachusetts. Despite fears that the new approach would encourage lawsuits, the opposite has proved true. , the number of lawsuits was cut nearly in half, and the hospital system saved about $2 million in litigation costs in the first year after the new model was adopted in 2001.

“The whole point of this isn’t to drop malpractice costs, it’s to drive patient safety,” said Richard Boothman, the University of Michigan Health System’s executive director of clinical safety and chief risk officer, who launched the program after a career defending doctors and hospitals. “We need to hard-wire as quickly as possible the lessons of these cases.”

In most hospitals, Boothman said, patient safety experts do not routinely talk to risk managers who handle malpractice claims. As a result, valuable information about preventing errors is lost.

In The Dark

Most patients never learn they are victims of a medical error. A landmark 1991 Harvard study found that of people harmed by errors file a lawsuit. Those who do face daunting odds: Patients lose of malpractice cases. Huge , combined with laws that have reduced damage awards in many states, have left many because plaintiffs’ lawyers are paid on contingency. Malpractice cases typically take three or more years to resolve. In the interim, many injured people struggle to pay for care.

Litigation “is a tortuous process for patients and health care workers,” said , who spent five years seeking answers about the 2003 death of her newborn son from a Chicago hospital that denied any wrongdoing.

“We later learned that this had happened to a family before us and another seven months after,” said Daley Ullem, a former McKinsey & Co. consultant whose ruptured uterus went untreated for an hour. She said she received a $4 million settlement before trial, which she offered to give back to the hospital to fund safety improvements. The hospital refused.

Disclosure efforts also face stiff resistance from doctors, insurers and lawyers, including defense attorneys for whom speedier resolution means fewer billable hours.

Despite laws in most states that prevent apologies from being used against doctors in lawsuits, many worry that it will make patients more likely to file suit, said Thomas Gallagher, a University of Washington professor of medicine who has written extensively about disclosure. A recent study found that of 300 primary-care doctors would not fully disclose a delayed breast cancer diagnosis to a patient.

Doug Wojcieszak 鈥� who founded an Illinois-based disclosure advocacy group called “Sorry Works!” 鈥� said one Iowa doctor told him that if he started apologizing when things went wrong, “he’d be doing nothing else all day long.”

Insurers are also leery, said Brian Atchinson, president of Physician Insurers Association of America, the trade association for liability insurers, which was involved in the development of CANDOR. “Some states are more conducive to this than others,” he said. “But there are those who don’t believe the benefits outweigh the risks.”

Lawyer Joanne Doroshow, director of the at New York Law School, expressed worry聽that disclosure programs may take advantage of vulnerable patients who are not represented by a lawyer. “The hospitals are in control of it, and it’s still in their interest to try and limit compensation to patients,” she said.

Jeffrey Catalano, a Massachusetts plaintiffs’ lawyer who is president of the state bar and a participant in that state’s disclosure program, says that patients should be represented early in the process. “I think if there’s a good attorney present, there’s no way a client is going to be shortchanged,” he said. “Good attorneys know this: Medical malpractice cases are hard to take to trial. If a client can get $1 now rather than risking getting nothing [at trial] for the prospect of $1.50 later, it may be better to take the $1 now.”

Doing The Right Thing

The country’s began 30 years ago with a doctor’s desire to do the right thing.

Pulmonologist Steve Kraman, newly named as chief of staff for what is now the Lexington Veterans Affairs Medical Center in Kentucky, said he faced a problem in 1987: how to handle the death of a middle-aged woman caused by an “undeniable error,”聽a massive overdose of potassium.

“If we had said nothing, [the family] never would have known a thing,” said Kraman, who was also the hospital’s risk manager. “We never would have gotten sued. But I just didn’t feel that was right.” So he suggested to the hospital’s lawyer that they come clean to the patient’s two adult daughters, from whom she was estranged.

“I sat down and told them exactly what happened, that we were responsible for it, that they should hire a lawyer and we were going to negotiate a payment,” he recalled. Two months later, the family was paid $250,000.

From then on, Kraman said, all cases involving errors were handled similarly. “We paid out for things that nobody could have sued for in their wildest dreams,” said Kraman, who is now a professor at the University of Kentucky. Some patients declined the cash, he said, because they feared it would “ruin their relationship with the doctor.” Kraman said he refused to pay a dime in cases where no injury could be proved. “That just alienates doctors and nurses who feel like you’re throwing them under the bus.”

Kraman said he had several advantages: Doctors were employed and insured by the VA system. Payments, which averaged $16,000, were made from the U.S. Treasury, not the hospital coffers. And the program had the support of the hospital’s director and lawyer as well as the U.S. attorney for Kentucky.

“This has to be done from the top down” or it won’t work, Kraman said. “The message has to be ‘This is how we do business.'”

When Boothman arrived at the University of Michigan in 2001 鈥� after two decades defending doctors, including an orthopedic surgeon who had been sued 21 times 鈥� he decided to try a similar approach. That included encouraging staff to report errors and bad outcomes; reports jumped from 2,400 a year to more than 34,000.

“You have to normalize honesty,” Boothman said, “to create a culture of continuous improvement.” Applying the lessons gleaned from those errors, he said, has helped make care safer.

“Litigating a case for three years and telling everybody, ‘Don’t talk about it and don’t change anything,’ is immoral and counterproductive,” he added. “I don’t serve my organization well by defending care we shouldn’t be defending.”

“Today we’re often at the bedside as soon as things happen,” he said. Patients and their families are interviewed as part of the hospital’s investigation of the facts, something that does not happen in traditional litigation.

Like Kraman, Boothman said he worries that some hospitals are using disclosure to cherry-pick small or unwinnable cases, not as a standard approach.

A Test Case

Orthopedic surgeon P. Justin Tortolani remembers with sickening clarity the moment he realized that a device he was installing had gone too far, penetrating Jack Gentry’s spine. The 60-year-old retired police officer, who once had hiked the entire Appalachian Trail, was instantly paralyzed from the neck down.

“You can’t really believe it’s happening,” said Tortolani, Union Memorial’s director of spine surgery. Summoning his years of training, the surgeon formulated a plan and steeled himself to tell Teresa Gentry what had happened. It was the first of many conversations about the accident that he would have with the family.

“We didn’t want to go through litigation, we didn’t need to go through litigation,” said Larry Smith, MedStar’s vice president for risk management. MedStar uses CANDOR in about a dozen cases with substantial damages annually.

MedStar executives “told me what had happened, why it happened, that it was directly or indirectly their fault and that whatever I needed I should ask for,” Gentry recalled. MedStar paid for five months of inpatient rehab 鈥� Gentry’s insurance would have covered only two weeks 鈥� modifications to the couple’s home, a $45,000 wheelchair and a new wheelchair-accessible van. It provided a case manager, a home-care nurse and $15,000 for incidental medical expenses.

“Because of the nature of Jack’s injury, we would have had to mortgage everything to pay for his care” otherwise, Teresa Gentry said.

Early on, Gentry said, his older brother, a Baltimore malpractice lawyer, expressed bafflement at MedStar’s approach. “He said as long as we were getting what we needed, to just go with it,” Gentry recalled.

At the end of two years, the case was settled with a confidential payment negotiated by lawyers for the couple, MedStar and the device manufacturer.

“I felt like it would take care of Jack for the rest of his life,” said Teresa Gentry, adding that the couple had been prepared to file a lawsuit if an agreement could not be reached. “Did I get enough to pay for everybody’s pain and suffering and trauma?聽No.”

“I was very skeptical in the beginning of this whole process,” she recalled, but she said she believes it has worked well, as does her husband.

Tortolani said he feels “remorse, guilt and sorrow for Jack and his family. This shakes you to your core,” he said. MedStar officials have been “unbelievably supportive,” Tortolani said, and he remains deeply grateful to the Gentrys. “My relationship with Jack has never been stronger.”

Donna Helen Crisp says she thinks she would have been less traumatized had the North Carolina hospital and her surgeon not stonewalled her. “I would have been deeply depressed that I had such a bad experience, but I could have moved on with my life,” said Crisp, who has written a book about her experience entitled “Anatomy of Medical Errors: the Patient in Room 2.” Being denied the truth left her with “no way to put it into perspective.”

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Often called device reps — or by the more cumbersome and less transparent moniker “”聽— these salespeople are employed by the companies that make medical devices: Stryker, Johnson & Johnson and Medtronic, to name a few. Their presence in the OR, particularly common in orthopedics and neurosurgery, is part of the equipment packages that聽hospitals typically buy.

Many “people who don’t work in health care don’t realize that industry reps are sometimes in the OR,” said Josephine Wergin, a risk management analyst for the ,聽a Pennsylvania nonprofit that conducts research on medical subjects for the health care industry. “A lot of times they are the real experts on their products.”

Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, experts say, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their 听诲别辫别苍诲.

Although they don’t scrub in, reps are expected to be intimately familiar with the equipment they sell, making sure it is at the ready for the surgeon and poised to answer technical questions.

Who’s The Expert?

But how much influence do reps wield, how necessary and costly are their services and does their presence in the OR, which may not be disclosed to patients, raise ethical questions about informed consent? A 聽has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a who had not graduated from high school tried for three hours to fix a prosthetic hip while a surgeon allegedly left the OR.

Despite their role, device reps have received little scrutiny, in sharp contrast to drug salespeople, whose role has been the subject of considerable research.

“There’s so little public awareness of this,” said Adriane Fugh-Berman, an associate professor of pharmacology at the Georgetown University School of Medicine and director of , a project that focuses on prescribing and drug-marketing practices. Fugh-Berman is the coauthor of a 聽that raises questions about whether surgeons rely too heavily on reps for technical聽expertise and assistance, to the potential detriment of patients.

But the cost of medical devices, an industry with about , combined with concerns about conflicts of interest by doctors who as part of the Affordable Care Act, has resulted in increased scrutiny, as hospitals from Savannah to Stanford聽seek to standardize and circumscribe the activities of device salespeople.

Several high-profile lawsuits have played a role, among them a 2006 Ohio case in which a surgeon and a rep were ordered to pay a patient $1.75 million after botched brain surgery. The salesperson had wrongly assured the surgeon that a bone cement was suitable for sealing a hole in the patient’s skull. In 2003, Endovascular Technologies pleaded guilty to 10 felonies in federal court and paid more than $92 million in criminal and civil penalties for covering up problems including 12 deaths associated with an abdominal device. Doctors had been removing the device using that had never been approved by the Food and Drug Administration.

Some hospitals, most notably Loma Linda University Medical Center in California, have in orthopedics, buying implants directly from the manufacturer at a substantial discount and training surgical technicians to take their place in the OR. Loma Linda’s chief of orthopedics said the hospital has saved about $1 million annually, a savings of 聽on the cost of the devices, without affecting outcomes.

“I think there is a role” for reps, said Lisa McGiffert, director of the Consumer Reports . But, she added, when it comes to choosing the best device — such as a prosthetic knee — “can the patient trust that they’re getting the expertise of the doctor or the influence of the rep?”

The presence of device reps in the OR, she added, also raises questions about the adequacy of consent, if patients are not explicitly informed of their presence.

Learning On The Fly

ECRI recently repeated its recommendation that hospitals obtain explicit written consent from patients if reps are to be present and warned surgeons against learning “how to use … devices on the fly.”

How often that happens is unclear, because what happens in the OR tends to stay in the OR. A suggests that reps’ over-involvement is not uncommon.

A survey conducted by researchers at New York’s Albany Medical College found that 88 percent of 43 device reps said they had provided verbal instructions to a doctor during surgery, while 37 percent had participated in a surgery in which they felt their involvement was excessive, often because the surgeon lacked sufficient expertise. Twenty-one percent said they had direct physical contact with hospital staff or a patient during an operation, which could violate hospital policy as well as state law.

Terry Chang, associate general counsel of , a device industry trade association, points to its code of ethics as well as 聽issued by the American College of Surgeons, which state that reps are to refrain from medical decision-making and participating in surgery.

But Chang says that reps, who have witnessed dozens if not hundreds of the same procedures, provide an essential benefit for doctors and patients. They “are only present at the behest of the physician and only as a trainer,” and they provide “a live interactive resource.”

Their value, Chang said, lies in their expertise, which can make surgery faster and more efficient. “For a lot of institutions, it’s a bandwidth issue,” he said, echoing a finding in Fugh-Berman’s study that some surgeons prefer working with reps because they are more knowledgeable than hospital staff.

Gerald Williams, a Philadelphia joint replacement specialist who is president of the 18,000-member , agrees. “Even if a surgeon is extremely familiar” with a device, “there are different teams scrubbing in” who typically have less familiarity with the procedure and the surgeon’s process than a rep with whom a surgeon regularly works.

“Their presence is dictated by the complexity of the surgery,” he said. “They are probably there close to 100 percent in complicated cases such as spine surgery and joint implants.”

Williams said he doesn’t tell his patients that a rep will be in the room, adding, “I don’t tell them there’s a circulating nurse, either. My patients look at me as being the captain of the ship. I think if I told them about a rep, they would all be supportive of it.”

While salespeople have been in operating rooms for decades, their participation mushroomed beginning in the late 1990s with the proliferation of total joint replacement operations, said Linda Groah, the longtime executive director of , the Association of periOperative Registered Nurses.

These days, “there’s much more control of the reps,” she said. “They just don’t come through willy-nilly.'”

But Jeffrey Bedard’s 2014 study about their role in the OR makes it clear that in some cases, there may be a chasm between guidelines and actual practice.

Bedard, who conducted his research as a graduate student in medical ethics, said it was prompted by his experience as an orthopedic device rep in the late 1990s. He subsequently became a drug salesman and now works in the pharmaceutical industry.

Bedard vividly remembers participating in one case involving a patient in her mid-40s. The surgeon, with whom he had not previously worked, refused all preoperative training, including watching a video, on a new $10,000 hip replacement system. “He said, ‘You’re going to be there, right?'” Bedard remembers being asked.

“To say that the case was a train wreck would be an understatement,” Bedard recalls. The surgeon repeatedly cursed at him and at the circulating nurse, who continually monitors the patient and is responsible for ensuring that the proper equipment is available, as he struggled to perform the procedure. “I had to hold up the illustrated surgical technique and talk him through the case step by step,” Bedard remembered. “I was absolutely beside myself.”

Bedard recalled that when he called his supervisor to report what had happened, “my boss said: ‘You just made $1,000 for three hours’ worth of work. What are you complaining about?'”

Judging by the responses to his anonymous survey, which found that 37 percent of reps said they believed they had been excessively involved in an operation and 40 percent had attended a surgery in which they questioned the surgeon’s competence, Bedard said little appears to have changed. “As a rep,” he said, “you’re paid to sell, to grow your business.”

Two years ago, Gary Botimer, a joint replacement specialist who is chief of orthopedics at Loma Linda, undertook a radical experiment: He got rid of reps in joint replacement cases. Botimer negotiated a steep discount on the price of artificial joints bought in bulk from a well-known American manufacturer and sent hospital surgical techs to the technical training given to device salespeople.

“It took me two years to convince the administration” to do this, recalled Botimer, who said that one surgeon, who had significant financial ties to a manufacturer, quit. “I took a lot of bullets.”

“What we basically did is to take the skill set of the reps and replace it with our own employees, who don’t have a conflict of interest,” Botimer said. “It’s very easy to train your own people. We have found that the techs are better than the reps.”

The ‘Rep-Less Model’

To lay the groundwork, Botimer said he and other surgeons reviewed the literature to select the best implants as the hospital’s standard. After the program was launched in 2014, Botimer said, he and his staff tracked the outcomes of all 500 joint replacement cases for one year to see if the “rep-less model” was equivalent. No difference in outcomes was detected, he said, but the hospital saved $1 million each year. (While standard implants are used in about 90 percent of cases, Loma Linda surgeons are free to use other devices if they believe doing so is in the patient’s best interest.)

The program has been so successful that it is being extended to other orthopedic surgeries, such as trauma and spine operations, he said. Botimer added that he is fielding inquiries from other hospital systems contemplating a similar move.

“This is a big change in the culture, and no one makes that change easily,” he said. “You have operating [room] personnel who’ve only known one way of doing things, doctors who are afraid to try it and administrators worried that docs would turn on them. We’ve spent a couple of years proving to everybody that their worst fears didn’t happen.”

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In 2003, beset by $30,000 in tuition debt and imbued with a burst of altruism, Eastman, a college senior, decided to donate her eggs to help an infertile couple have a baby. Over the next decade she donated nine more times, earning a total of about $20,000 — money that helped Eastman and her then-husband buy a house.

“When I think back, I think, ‘God, how stupid was I?'” said Eastman, now 34, who works as a 911 operator near Seattle. She made her final donation in 2013, months before she was diagnosed with Stage 4 metastatic breast cancer — a rarity in someone so young who has no family history of the disease.

Eastman said that when she asked her oncologist whether her cancer might be related to her egg donation, which involves the use of hormones to , he replied that he didn’t know, adding, “Well, there are risks.”

Although Eastman believes that being an egg donor was the cause of her estrogen-fueled cancer, experts say it is impossible to know. Studies of the long-term impact of egg donation on donors have never been done, even though the practice dates back more than 30 years.

Despite sporadic reports of subsequent infertility and a variety of cancers, , it isn’t known whether these problems are linked to the process or are simply the result of chance.

Fertility specialists say that egg donation is safe and involves the same process as , which uses drugs to stimulate and regulate egg production. A 聽of 25 studies seeking to evaluate the risks between ovarian cancer and the use of fertility drugs found “no convincing evidence” of an increase in the risk of invasive ovarian cancer.

“There are no long-term adverse risks of IVF” or egg donation, said Richard J. Paulson, president-elect of the (ASRM), which represents fertility specialists. Paulson heads the infertility program at the University of Southern California, one of the nation’s oldest egg donor programs, which was established in 1986. “All the data we have so far seem to indicate no long-term problems.”

But others say the matter remains unsettled because donors haven’t been studied.

“There is a total lack of information about the long-term [effects],” said Timothy R. B. Johnson, the longtime chairman of the department of obstetrics and gynecology at the University of Michigan Medical School.

Johnson supports the establishment of a national registry to track the health of egg donors. “No one’s collecting the data” on donors, he said, adding that the fertility industry is largely unregulated. Once their eggs are retrieved, donors are sent home with little or no follow-up.

A transaction once shrouded in secrecy, the internet now hosts a thriving and , largely supplanting leaflets on college bulletin boards and ads in campus newspapers, the traditional methods of recruiting fertile young women. Payment varies, currently starting at about $3,500 per cycle and sometimes exceeding $50,000, depending on the location of the clinic or egg brokerage and the donor’s characteristics. An Ivy League education, Asian descent (there is a paucity of donors), exceptional looks and a previous donation that led to a birth command higher reimbursement.

The demand for donor eggs has increased rapidly in the past decade. Nearly every state has at least one fertility clinic, said Judith Daar, a specialist in reproductive law and a professor at Whittier Law School in Costa Mesa, California. A found a significant increase in the use of donor eggs between 2000 and 2010, from 10,801 to 18,306. Daar estimates that about 10,000 babies born in the United States in 2013 were conceived using donor eggs.

But questions about egg donation abound, said veteran women’s health advocate Judy Norsigian, a cofounder and former executive director of the Boston-based advocacy group . Among the unknowns: How many women have donated eggs? (The number is believed to be in the thousands.) How many times are they donating? (The ASRM recommends a lifetime maximum of six.) Which drugs are they being given, and in what doses? How common is ,聽a painful condition in which the ovaries swell? Severe cases can lead to a stroke or even, rarely, to death.

Informed Consent

It is also difficult, health advocates say, to gauge how aware potential donors are — or what they are told — about short- and long-term risks. A 聽of 80 donors found that “a rather large and troubling minority” — 20 percent — said they did not know of possible health risks. And while 8.8 percent said they knew that the process entailed some pain, 45 percent reported experiencing “notable pain.” A 聽of egg donation ads placed on Craiglist, one of the chief venues for egg donors, found that “the vast majority” do not include risk information.

Norsigian said she worries that donors are being falsely reassured that the process is safe, without being told that there is no definitive research.

“Absence of evidence of harm is not proof of safety,” she said. “Fertility doctors by and large don’t want to shine a light on what is a really lucrative field.”

Studies of IVF in infertile women have produced conflicting results: Some have found no increase in cancer, while others reported an of uterine and . The meaning of this finding is unclear, because infertility itself is a risk factor for some malignancies.

Some fertility specialists are cool to the idea of a registry, which they say is unnecessary. “I can’t even imagine logistically that such a thing would ever take place,” said Preston Sacks, a reproductive endocrinologist affiliated with Columbia Fertility Associates, which has three offices in the Washington, D.C. area. In Sacks’ view, concerns about medical privacy would prove insurmountable.

Judy E. Stern, a professor of pathology and obstetrics and gynecology at Dartmouth who oversees the, a voluntary database that includes about 70 egg donors, said she believes that donor data is urgently needed.

“I think if there had been huge health risks [from IVF], we would have seen that over the last 30 years,” she said. “That suggests the absolute risk is fairly low. But we don’t know anything about the donors,” whose risks may differ from infertile women undergoing IVF. “These are presumably fertile women and they may respond to medications [differently] than infertile聽women.”

Stern co-chairs an egg donor task force of the Society for Assisted Reproductive Technology, which represents clinics performing IVF. She said SART is considering the establishment of an egg donor registry. “If we don’t understand the risks for donors, we need to, because of the women who are freezing their eggs” for possible later use, she said.

How Naive?

Ari Laurel, now 26, donated her eggs to an Australian couple in 2014. Laurel said that she knew she didn’t want children and that Asian donors like her were in demand. Her $12,000 payment financed a year of graduate school. “The agency I went through seemed to ask eugenic-type questions” such as skin color and whether she had been in gifted programs. Laurel said she was聽also asked to submit her undergraduate transcript and GRE scores.

Laurel, who lives in Missoula, Montana, said she felt well informed by the clinic about possible health risks and suffered no complications. Before deciding to donate, she contacted , an online group founded in 2013, and spoke to one of its founders.

She has no regrets and is happy that she was able to help an infertile couple have a baby. But when the clinic contacted her for a second donation, Laurel declined. “I found the process pretty exploitative,” she said.

Her savvy is not typical of the 60 egg donors whom medical anthropologist Diane Tober has interviewed for a film she is making. Tober, an assistant professor of nursing at the University of California, San Francisco, said that some donors seemed naïve about the process, which many found more physically and emotionally daunting than they anticipated.

“They expected that the doctor and the staff was going to look out for them as they do for their infertility patients,” Tober said. The pitch was “cloaked in this language of ‘Be an angel, help someone and get paid for it.'” Some donors, she said, were motivated by altruism; others said “it would be so cool” to help gay men create a family.

In Tober’s view, egg donation more closely resembles kidney donation than sperm donation. Both egg and kidney donation, she said, “involve drugs and medical procedures that are of no benefit to the donor.”

Sacks, the Washington fertility specialist, said that about 10 percent of the prospective donors he evaluates decide against completing the process once he tells them what’s involved. Donors are paid $8,000 per cycle, he said, and have included a teacher, a lawyer with a major Washington firm and a school bus driver; few are college students.

After undergoing medical and psychological screening and being matched with a recipient, the donor takes birth control pills to synchronize her menstrual cycle with that of the recipient. After that, she typically , a hormone approved to treat advanced prostate cancer. Lupron, which prevents the ovaries from releasing an egg, is not approved for use in fertility procedures. Some women’s health advocates say they are concerned that donors are not told the drug is being used “off label” for an unapproved use. (Off-label use of drugs is common in all fields of medicine.) Lupron’s 聽have aroused concern; they include joint pain, acne and osteoporosis.

Lupron is followed by injections that stimulate egg production. After that comes a carefully timed “trigger shot” of a hormone that causes ovulation. Within roughly 48 hours, the donor is sedated and a needle is inserted transvaginally into the ovary to extract each egg. Typically no more than 20 eggs are harvested.

Thinking It Through

Clinical psychologist Andrea Mechanick Braverman, who screens donors for several Philadelphia area fertility clinics, said that one of her goals is to ensure that donors “know what they’re doing.” She worries that some underestimate the invasiveness of the procedures and the long-term emotional ramifications, such as feelings of regret. “You try to get them to think it聽through.”

Sindy Wei, 39, thought she had. Wei, an assistant professor of radiology at UCLA, donated her eggs in September 2001; she was then a 25-year-old M.D./Ph.D. student struggling to pay her rent in Los Angeles.

Wei, who has testified about her experience before a California Senate committee seeking greater protection for egg donors, said she researched the potential risks and found none.

“I didn’t know the research hadn’t been done because the donors hadn’t been followed,” Wei said. A San Francisco clinic paid her $6,500, she said, and extracted a whopping 60 eggs.

When Wei complained in the recovery room that she felt ill, she said doctors tried to discharge her and urged her to fly home to Southern California. Wei said she refused to leave, and eight hours later she was admitted to a hospital after her blood pressure plummeted because she was bleeding out. Doctors discovered that Wei’s ovarian artery had been nicked during the retrieval process and聽her abdomen had filled with blood. She received several transfusions and underwent emergency surgery, then spent several days in intensive care.

Wei was left with bladder spasms and infertility and underwent six rounds of fertility treatment when she was trying to get pregnant. She said her biggest fear is that she will develop cancer from the hormones she took as a donor and infertility patient.

“I think egg donation should be a choice for young women,” Wei said. “But they should really know what the risks are. And unless it’s studied, there’s no way to tell.”

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But Happli’s operation had to be aborted after it proved too difficult. Several months later, the pipe fitter, now 58, traveled to Froedtert Hospital in Milwaukee, 175 miles from his home. His operation, one of 127 Whipples done at Froedtert last year, was performed successfully by chief surgeon Douglas B. Evans.

The procedure involves removing part of the pancreas and small intestine as well as the gallbladder, and reconnecting the digestive organs. It proved to be particularly complicated in Happli’s case, Evans said, because of tissue damage caused by radiation treatment for his lymphoma.

“If this patient is not getting referred [to a specialist], then who is?” asked Evans, who said he has seen a recent uptick in patients treated unsuccessfully by inexperienced surgeons at smaller hospitals.

The largely unfettered ability of surgeons with minimal expertise to perform high-risk procedures — particularly at hospitals that lack experience caring for significant numbers of patients — has been the subject of a contentious, long-running battle known as the volume-outcome debate.

A groundbreaking found that patients who underwent operations at hospitals that did more of those surgeries had significantly lower death rates than those treated at hospitals where they were done infrequently. 聽has since been replicated repeatedly across many specialties and found to apply to surgeons as well as hospitals. Last month, a found that the risk of complications was far higher among surgeons who performed only one thyroid removal annually than among those who did 25 or more of the tricky procedures per year.

Recently the volume battle was reignited when a trio of prominent health systems — Johns Hopkins, Dartmouth-Hitchcock and the University of Michigan — pledged that they will require their surgeons and 20 affiliated hospitals to meet minimum annual thresholds for 10 high-risk procedures. The three systems have asked other hospital networks around the country to join them.

Under the terms of , believed to be the first of its kind, surgeons must perform at least five pancreatic cancer surgeries annually in hospitals where 20 such operations are done each year. For knee or hip replacements, the requirement is 25 per surgeon and 50 per hospital. There are provisions for emergency surgery and for surgeons who sometimes do not meet the threshold because they were on leave; such surgeons might be required to perform a certain number of procedures under聽supervision.

“There is this intractableness of patients undergoing surgical care in places that have no business doing it” or performed by “hobbyists” — surgeons who infrequently perform risky surgeries, said , chief academic officer at Dartmouth.聽Birkmeyer devised the pledge with , an internationally known expert who directs the Armstrong Institute for Patient Safety and Quality at Johns Hopkins.

At large teaching hospitals, Birkmeyer noted, “there are usually one or two or three surgeons who are recognized as go-to doctors” for certain procedures and do them frequently. “But there’s this tail of other surgeons who do only a few a year,” such as a shoulder surgeon who performs a handful of hip replacements or a breast cancer surgeon who occasionally attempts a Whipple.

“We decided to use volume as a pilot case, an initial foray into setting quality and safety standards,” he said. “And we wanted to do it in a way” that was not subject to the discretion of hospital officials.

Critical Information

As smaller community hospitals affiliate with larger ones, the questions of which surgeons should do which procedures and where are increasingly confronting health systems. Hospitals of all sizes — both large academic centers and smaller community institutions — face a variety of sometimes competing incentives: to retain lucrative surgical cases and to avoid angering surgeons, who fiercely prize autonomy and wield considerable clout because they generate substantial revenue. And while hospitals聽formerly reaped a if patients suffered complications and had to be readmitted, they now face penalties under the Affordable Care Act.

The , a nonprofit organization that represents large employers and purchasers of health care and seeks to advance patient safety, has focused on volume in its hospital rating system. “Volume is a really critical piece of information,” said the group’s chief executive officer, .

“I think every medical staff should be grappling with these volume benchmarks,” she said, endorsing the pledge. “It’s fundamental.”

Ashish K. Jha, a practicing internist and professor of health policy at Harvard’s T. H. Chan School of Public Health who has written about efforts to improve medical quality, calls the pledge “very reasonable.”

Low-volume hospitals, he said, typically lack specialized teams to care for patients as well as state-of-the-art equipment and systems designed to prevent or quickly spot complications — critical factors in improving outcomes. “None of us care about volume; we care about outcomes, and volume is a surrogate” measure of outcomes, Jha noted. “Even though we’ve been talking about this for 35 years, a ton of high-risk surgery still happens among low-volume providers.”

But surgeons’ groups and the president of the Joint Commission, the Chicago group that accredits the nation’s hospitals, have criticized the pledge as simplistic and overly prescriptive. Some officials say they fear it could unfairly penalize low-volume surgeons and smaller hospitals that have good outcomes.

“There’s room to improve in low-volume and high-volume hospitals,” said Kevin Bozic, chairman of the department of surgery at the Dell Medical School at the University of Texas at Austin, who heads the committee on research and quality for the American Academy of Orthopaedic Surgeons. “There are high-volume, low-quality hospitals” as well as the converse.

“I know Harvard may be better than McPherson, Kansas,” said Tyler Hughes, a surgeon at the 25-bed hospital in McPherson and a director of the American Board of Surgery. “But for many patients, the best possible surgery is closest to home.”

Irate Surgeons

Although patient-safety experts and some insurance companies have long encouraged patients, especially those with serious illnesses or complex diagnoses, to seek care from experienced specialists at high-volume hospitals, there is little to prevent doctors and hospitals from doing whichever surgeries (other than organ transplants) they see fit, no matter how rarely they do them.

Many patients don’t know to ask a doctor about volume or outcomes or are unable to ferret out relevant information when choosing a surgeon or hospital. One reason, Leapfrog’s Binder said, is that much important information such as complication rates remains hidden. Hospitals report detailed data about surgical outcomes to registries for internal use, but the information is not publicly available.

Kerry O’Connell, 59, a Denver construction executive, said that only after a botched elbow operation that required seven corrective surgeries did he learn that his was the second such procedure his orthopedist had performed. “I went to the one clinic where the ER sent me, and the surgeon seemed like a nice guy,” he said.

“We don’t have enough transparency in health care,” Binder said. “It’s the first thing everyone wants to know: Who’s the best surgeon? And anyone in health care picks up the phone and asks their friends.”

Recently, Binder notes, there have been new efforts to inform patients. In the past year, the journalism organization ProPublica and Consumer’s Checkbook have launched databases that rate surgeons. Since 1995 New York state has published some data on heart surgeons. And Consumer Reports and the federal government’s Hospital Compare website provide hospital-specific information.

A report by Leapfrog found that in 2013, one-third of hospitals that performed procedures to remove all or part of the esophagus, a demanding surgery to treat cancer, did only one or two annually, far below the level needed to achieve proficiency. A of an extremely low-volume Florida heart surgery program launched in 2011 found that six babies died in a two-year period, far more than expected; the program has since closed. And a last year found that Medicare patients who had knee replacements at the lowest-volume hospitals in the country were 70 percent more likely to die than those whose surgery was performed at the highest-volume centers; for hip replacement, the figure was 50 percent.

Disparities can be seen among hospitals in the same system, Birkmeyer noted.

“One of our highest priorities is insuring consistent quality and safety” regardless of where a patient seeks treatment, he said. In the past decade, Dartmouth has grown from a single hospital in Hanover, New Hampshire, to eight in northern New England. Baltimore-based Hopkins has affiliated with smaller hospitals in Washington, D.C. and suburban Maryland.

Among the most irate reactions Birkmeyer said he encountered came from about 10 surgeons affiliated with Dartmouth’s main hospital who were told they would no longer be allowed to do procedures for which they didn’t meet annual minimums. “They said things like, ‘I’ve been credentialed to do this for 20 years and I’ve never had a complication, and now you’re telling me I can’t do it?’ “

That anger and the months required to get the boards of hospitals and their executive committees to agree to the new rules may be among the reasons only three systems have signed on so far, Birkmeyer said. More than a dozen others have expressed interest.

Some surgeons say that the focus on volume is misguided.

The problem “is actually much more complicated than volume” said David Hoyt, executive director of the American College of Surgeons. Hoyt said that the group is drafting its own guidelines that will address volume.

Beyond Numbers

To Mark Chassin, president of the Joint Commission, the pledge misses the mark. “The surgeon’s contribution to the outcomes patients experience is only one component,” he said.

“Volume should never be used by an accrediting organization as a measure of quality” because it is too imperfect a measure, Chassin added.

Patients can help protect themselves, he added, by taking “as much responsibility and interest” as possible in their care.

In the view of general surgeon Linda Halderman, doctors are the best judges of their abilities. “Every surgeon has to exercise judgment of their own capabilities” and know when to refer to a more experienced colleague, said Halderman, who is based in Selma, California.

But Harvard’s Jha disagrees. Many surgeons, he said, tell him they “have excellent results and I’ll say, ‘How do you know? Do you actually track your outcomes?’ ” Most, he said, do not.

Two months ago, Linus Linaweaver, 76, chose to undergo elective abdominal surgery in his home town of McPherson, Kansas, after robotic prostate surgery at a larger hospital in Wichita nearly killed him and left him with a colostomy.

“I wanted to be back in our town,” he said, adding that he had confidence in Tyler Hughes, his surgeon, and McPherson Hospital. His seven-hour operation went well, and Linaweaver recently said he is “almost back to normal.”

James Happli is back at work after a year’s medical leave. Following his failed Whipple surgery, the local surgeon proposed trying again. That offer was withdrawn after a second specialist refused to participate. At that point, Happli was referred to Evans in Milwaukee.

If he had it to do over again, Happli said, “I would have gone to a bigger place” and a more experienced surgeon the first time.

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“I’d just read about how abdominal CTs are one of the highest-risk tests [in terms of radiation exposure] and should not be repeated unless there was a major change,” said Hanvik, who lives in Minneapolis. In the past, antibiotics and a bland diet had quelled her recurrent diverticulitis. Hanvik said she wanted to follow that approach again but avoid a scan, which contains about 10 millisieverts (mSv) of radiation, the rough equivalent of 听辞谤 .

“I don’t think she appreciated my uncharacteristic behavior,” said Hanvik, adding that her primary care doctor reluctantly agreed, but made her promise to return within 48 hours if she did not improve. Hanvik got better, as she had previously.

Hanvik’s newfound assertiveness and her questions about the necessity of a CT scan reflect a growing awareness of the potential pitfalls of diagnostic imaging, which in the past two decades has exploded into a .

Imaging has aided diagnosis and helped many patients avoid exploratory surgery, but it has also spawned concerns about misuse. Experts cite ballooning costs, including from duplicate procedures, potential harm from the tests themselves and the overtreatment of harmless conditions found during scans. These — so named because they are found unexpectedly — include聽benign lung and thyroid nodules and other common conditions that can lead to unnecessary and expensive workups as well as treatment that can cause complications.

Much of the attention has focused on , which use hundreds of X-rays to create detailed three-dimensional images that enable doctors to see things previously visible only through a biopsy or surgery.

Like X-rays and PET scans, CT scans use ionizing radiation, which can damage DNA and cause cancer. Two other imaging technologies, MRI scans and ultrasound, do not use radiation. CTs are used for a plethora of reasons, among them finding kidney stones, evaluating chest pain and detecting tumors or other abnormalities.

Widely hailed as one of the most important medical advances of the past century, CT scans were developed in the 1970s. Their use in the United States grew from 3 million in 1980 to in 2011.聽Although CT scans are an essential diagnostic tool, the Food and Drug Administration reports that an estimated of imaging tests are believed to be medically unnecessary.

“We have this view that we only really use imaging when it’s really necessary,” which is no longer the case, said Rebecca Smith-Bindman, a professor of radiology, epidemiology and obstetrics and gynecology at the University of California, San Francisco. “The truth is, now it’s ubiquitous. And many of these tests don’t need to be done.”

Like X-rays, CT scans represent a potentially significant health problem, one that experts say may not show up for years: cancer caused by radiation. In most cases, it is impossible to definitively attribute cancer to radiation exposure that occurred years or even decades earlier. And overall, the risk from a single scan is small: The that the additional risk of developing a fatal cancer from a scan is 1 in 2,000, while the lifetime risk of dying of cancer is 1 in 5.

The question of risk remains a matter of fierce debate among radiologists: Some say that the amount of radiation used in diagnostic studies is safe and that the benefits far outweigh the small chance that a person will develop cancer. But other experts, including Smith-Bindman, say that while patients should never avoid scans that are medically necessary, excessive radiation doses and indiscriminate use of imaging pose a clear and .

Studies published and by teams from Columbia University and the NCI predicted that up to 2 percent of future cancers — about 29,000 cases and 15,000 deaths annually — might be caused by CT scans. A by the Institute of Medicine found that the two environmental factors most strongly associated with breast cancer were radiation exposure and the use of post-menopausal hormones.

While a single scan would rarely be concerning, many Americans undergo multiple tests. A by researchers at Brigham and Women’s Hospital in Boston found that among 31,000 patients who had a diagnostic CT scan in 2007, 33 percent had more than five during their lifetime, 5 percent received 22 or more, and 1 percent underwent more than 38 scans.

From Necessity To Overuse

Some hospitals tend to perform double scans — one with a contrast agent and a second without it. Doctors sometimes refuse to accept or are unable to access radiology studies done elsewhere and send patients for duplicate tests at a facility in which they have an ownership interest. Doctors who have a in radiology clinics or who own scanners use imaging substantially more often than those who don’t, studies have found.聽And increasingly, specialists are requiring that patients get a scan before they first see a patient.

According to the FDA, which has launched an initiative to reduce unnecessary exposure to medical radiation, the effective doses from diagnostic CTs are “not much less than the lowest doses of 5 to 20 mSv received by some of the Japanese survivors of the atomic bombs” dropped over Hiroshima and Nagasaki in 1945. Some of these survivors have “demonstrated a small but increased radiation-related excess relative risk for cancer mortality.”

Radiation exposure is cumulative, and children, who undergo between annually,聽are much more vulnerable to its effects.

Concerns about overuse and potential harm have prompted actions by federal health officials as well as consumer and physician groups. These include the Image Wisely and Image Gently campaigns, as well as the national effort,聽which seeks to educate patients and doctors about unnecessary tests such as or back pain.

A “decision support” system that creates a set of standards for doctors to follow, pioneered at Massachusetts General Hospital in Boston, reduced the rate of inappropriate imaging tests from 6 percent in 2006 to 1.5 percent in 2014, said James Brink, the hospital’s radiologist-in-chief. A similar statewide program in Minnesota cut the growth rate from 7 percent per year to about 1 percent annually.

New 聽will require doctors to consider appropriateness criteria developed by the聽American College of Radiology when ordering imaging. Beginning this year, Medicare will reduce by 5 percent reimbursement for CT scans performed on machines that fail to meet modern standards, including the ability to automatically adjust radiation doses.

But significantly reducing the number of unnecessary CT scans may be an uphill battle.

A recent study found that doctors who order a lot of tests — a practice known as defensive medicine — get sued less often.

Some radiologists say they spend their days reading scans that trigger a cascade of follow-up tests and procedures for conditions that nearly always turn out to be benign. “I see two or three [incidentalomas] on every scan,” said , a radiologist at the VA Medical Center in West Haven, Connecticut, who teaches at the Yale School of Medicine. “I never see a normal patient.”

Financial incentives also fuel the casual use of scans. “Radiology has become an enormous profit” center for hospitals, Smith-Bindman said. “The amount we get paid is very high” under fee-for-service systems.

Patient demand is a key factor. Many people, unaware of the radiation risk, push for tests in the erroneous belief that they signify cutting-edge care. “If a patient requests [a CT scan] and a doctor says no, it could be a good starting point for a conversation,” said Orly Avitzur, medical director for Consumer Reports. But too often, doctors feel pressed for time so they just order the test. “As a practicing neurologist, I can tell you it is a very tough thing to say, ‘No, this is not needed at this time.’ “

To determine whether a CT is necessary, Avitzur said, patients should ask why the scan is being done, how the results might affect treatment and whether an alternative such as ultrasound or an MRI could be used instead.

How Much Is Too Much?

Among radiologists, the debate about the risk of cancer from diagnostic CTs rages.

“Everything we do in medicine involves trade-offs,” said Smith-Bindman, who directs UCSF’s Radiology Outcomes Research Lab. “The risks of radiation are real, and radiation leads to cancer. I think the data are quite compelling and not that hard to understand.”

But others disagree. “I don’t think the risks are as clear-cut” as Smith-Bindman contends, said Mass General’s Brink, vice chairman of the board of the American College of Radiology. In a he co-authored,聽Brink characterized the risk of cancer from diagnostic scans as “unproved” and “overemphasized,” based in part on uncertainty about the effect of radiation.

Scott Berger, director of neuroradiology at the Mount Kisco Medical Group in New York, agrees. “The risk of dying from a cancer that is not detected is thousands of times greater than” from radiation, he said. “These tests are lifesaving, they are great for patients.”

But Marta Hernanz-Schulman, medical director of radiology at the Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, is less gung-ho.

“Is radiation a real problem?” she asked. “We don’t know, but we need to act as if it were.” Studies performed in the United Kingdom 聽and Australia in聽 found an increase in cases of leukemia and malignant brain tumors among children and young adults who had undergone CT scans. One concern, said Hernanz-Schulman, a past president of the Society for Pediatric Radiology, is that many children undergo CT scans in adult facilities and may receive excessive doses because scanners are not adjusted聽between patients.

At Vanderbilt, children brought to the ER after a motor vehicle accident used to automatically get an abdominal CT scan. “Now we get liver enzymes first to see if they have a liver [injury] and we need a CT scan,” she said. In the past decade the number of CT scans has been cut by nearly half, she said.

Smith-Bindman said that excessively high radiation dosage is a problem requiring urgent attention. A 2009 study she led found that the actual radiation doses from CT scans varied as much as 聽for the same test performed at the same hospital, and these doses were much higher than those required to make a diagnosis. Except for mammography, there are no federal regulations governing radiation doses.

There are several reasons for the variation, Smith-Bindman said, including the failure to adjust the radiation dose based on body size and a desire to achieve more finely detailed images, which can be achieved by ramping up the dose. Nor are there national standards for technologists who administer CT scans, which involve increasingly sophisticated equipment. Some states don’t even require that they be licensed, allowing virtually anyone to operate the equipment.

“There’s no standardization of how these exams get conducted,” Smith-Bindman said. “There’s no oversight and no one’s responsible for this.”

Recently, she said, she spoke to a group of 300 radiology technologists and was “dumbfounded” by their questions. One asked her, “How do I pick a dose?” The technologist said she had devised her facility’s CT protocol, a job that is supposed to be performed by radiologists. Another said that in her hospital, “no one cares” about radiation doses.

Test Declined

Although Jean Hanvik avoided an abdominal CT after her diverticulitis flared, a few months later she had a different experience with a painful wrist. Before an orthopedist would see her, he required that she get an MRI scan, much of which she had to pay for out of pocket. It revealed that she had arthritis. Hanvik wonders why an expensive scan was necessary, particularly before ever talking to the doctor.

“I’m frustrated that diagnostic imaging has become the first line of defense,” she said. “I’m learning to ask a lot more questions.”

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