Sometimes a straightforward explanation and an apology for what went wrong in the hospital goes a long way toward preventing medical malpractice litigation and improving patient safety.

That’s what Michelle Mello, JD, PhD, and her colleagues found in a study published Oct. 2 in Health Affairs.

Mello, a professor of health research and policy and of law at Stanford University, is the lead author of the study. The senior author is Kenneth Sands, former senior vice president at Beth Israel Deaconess Medical Center.

Medical injuries are a leading cause of death in the United States. The lawsuits they spawn are also a major concern for physicians and health-care facilities. So hospital risk managers and liability insurers are experimenting with new approaches to resolving these disputes that channel them away from litigation.

The focus is on meeting patients’ needs without requiring them to sue. Hospitals disclose accidents to patients, investigate and explain why they occurred, apologize and, in cases in which the harm was due to a medical error, offer compensation and reassurance that steps will be taken to keep it from happening again.

Positive results

The study reports on the outcome of a so-called communication-and-resolution program at two large Massachusetts hospital systems. Mello and her co-authors found that the program not only yielded positive results in terms of liability costs but also led to significant patient safety improvements.

“In these programs, hospitals scrutinize every serious harm event to answer the question, ‘What can we learn?’” Mello said. “Traditionally, a risk manager’s focus has been on the patients who complain about the care or threaten to sue. But every patient deserves to know that what happened to them is being taken seriously.”

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Despite concerns that telling patients about errors and proactively offering compensation could cause liability costs to skyrocket, of the 989 adverse events reviewed for the study from 2013 to 2015, only 5 percent led to malpractice claims or lawsuits. And when the program did lead to compensation, the median payment was $75,000. By comparison, the median payment nationwide in 2015 when plaintiffs prevailed in malpractice lawsuits was about $225,000, Mello noted.

“Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively,” the authors wrote.

Pilot program

The authors focused on a program called CARe — Communication, Apology and Resolution — at six Massachusetts hospitals: Beth Israel Deaconess Medical Center and Baystate Medical Center, and two of each center’s community hospitals.

The hospitals demonstrated good adherence to the program protocol, the authors found. Physicians were supportive of the approach but did ask for better communication about the program and what was happening with their patients.

The low percentage of events that led to litigation should reassure hospitals concerned about the risks of being honest with patients, the authors wrote. A likely explanation, according to Mello, is that explaining why adverse events occurred defused patients’ anger. About three-quarters of the time, adverse events were not actually due to error, the study said. Rather, malpractice claims frequently arise when plaintiffs perceive that the health care providers communicated poorly or attempted to cover up negligence, the authors noted.

“Given the rarity with which communication-and-resolution events resulted in settlements, it is reasonable to wonder whether the programs are worth the time they require,” the authors wrote, “but risk managers in our study thought they were. By providing explanations and expressions of sympathy for harms not arising from negligence, communication-and-resolution programs may avert lawsuits springing from misunderstanding.”

Objectives and improved safety

The CARe objectives are to improve transparency surrounding events, improve patient safety, reduce lawsuits and support clinicians in disclosing error or injury.

Medical events were bumped to a CARe evaluation if they met a severity threshold of either causing permanent or temporary harm that led to an extended hospitalization, required an invasive procedure or led to at least three outpatient visits.

Of the 989 total events studied by the authors, 60 of them entered the CARe program because the hospital received notice that the patient intended to sue. Another 929 entered the program when an adverse event was reported that allegedly exceeded the severity threshold, or that met other criteria.

The protocol called for compensation to be proactively offered whenever a violation of the standard of care caused serious harm. Only 9 percent of cases met these criteria. The largest payment made was $2 million. In 181 events, in which compensation criteria weren’t met, hospitals offered to waive medical bills or made other modest gestures, like giving the patients meal vouchers and gift cards. About three-quarters of injuries didn’t qualify for compensation because the standard of care was judged to have been met — a proportion that is consistent with prior studies of medical injuries. About a third of the injuries weren’t caused by the medical care: For example, a patient contracted an infection in the hospital but died from other causes.

“These programs are usually talked about as a way to resolve cases of medical error, but what they do more often is encourage communication with patients about non-error events — as well as systematic evaluation of each event for patient-safety lessons,” Mello said.

The authors also noted that communication-and-resolution programs “can help hospitals foster a culture of transparency by supporting clinicians in making disclosures.”

The safety interventions identified in the CARe investigations included new labeling for high-risk medications, color-coded socks for patients at risk for falls, radio frequency identification tags for surgical sponges, improved interpreter services, improvements for managing the selection of implantables after surgery, and a multidisciplinary checklist for breech deliveries.

Other authors of the study are affiliated with Harvard, Tufts, Baystate Medical Center, and Beth Israel Deaconess Medical Center.

Women now have the option of getting screened every three or five years for cervical cancer, depending on which type of test they use, according to new draft recommendations from the U.S. Preventive Services Task Force.

The group of independent medical experts is recommending that women 21 to 29 years old get a cervical cytology (PAP test) every three years, while women aged 30 to 65 should either continue to get screened with a Pap every three years, or opt to be tested for the high-risk human papillomavirus (HPV) every five years.

“Cervical cancer is highly curable when found and treated early,” task force member Carol Mangione, MD, MSPH, said in a release on Monday. “Most cases of cervical cancer occur in women who have not been regularly screened or treated. Therefore, making sure all women are adequately screened and treated is critical to reducing deaths from cervical cancer.”

Despite the dramatic reduction of cervical cancer by half since the Pap test was introduced 40 years ago, nearly 13,000 American women are expected to contract this type of cancer this year. Of those, 4,200 are likely to die, according to the American Cancer Society. African-American and Hispanic women are at even greater risk.

The task force is an independent, volunteer panel of national experts in prevention and evidence-based medicine whose recommendations are widely followed by physicians and policymakers. They assign each recommendation a letter grade based on the strength of the evidence — and this recommendation comes with an A.

“We now have two effective screening strategies for women over 30, either cervical cytology every three years or HPV testing every five years,” said Douglas K. Owens, vice-chairperson of the task force.

Owens, a physician, professor of Stanford Medicine and director of the Center for Health Policy and Center for Primary Care and Outcomes Research, said that in women ages 21 to 29, a substantial portion of HPV infections resolve on their own. Cervical cytology, or Pap tests, remains the recommended screening strategy in this age group.

The advisory panel recommended against screening in women younger than 21 and older than age 65 years who have been adequately screened and don’t have a history of high-risk lesions.

The task force emphasized that cervical cytology tests remain an effective method of screening for cervical cancer, but that evidence published since its 2012 found that both Pap tests and HPV testing alone are effective ways to screen for cervical cancer in women aged 30 to 65.

“So women should discuss with their health-care provider which testing strategy is best for them,” Owens said. “What’s most important is that women get screened regularly.”

The Food and Drug Administration in 2011 approved the first test for HPV screening, a DNA test that looks for 14 types of the HPV virus, including types 16 and 18, which cause about 70 percent of all cervical cancers. In 2014, the FDA determined that the HPV test could be used alone instead of alongside the Pap test, which looks for changes in cervical cells.

The task force’s draft recommendation and evidence review have been posted for public comment on its website. Public comments can be submitted through October 9.

Rural areas of China have made remarkable progress in reducing adult mortality within the past 15 years yet broadened health insurance was not a casual factor in that decline, according to a new study by an international research team that includes Asia Health Policy Program Director Karen Eggleston.

The New Cooperative Medical Scheme (NCMS), a government-subsidized insurance program that began in 2002-03, expanded to cover all of rural China within a decade. Examining NCMS and cause-specific mortality data for a sample of 72 counties between 2004 and 2012, the researchers found that there were no significant effects of health insurance expansion on increased life expectancy.

The study, published in the September issue of Health Affairs, showed results consistent with previous studies that also did not find a correlation between insurance and survival, although much research confirms NCMS increased access to healthcare, including preventive services, and shielded families from high health expenditures.

Commenting on the study, Eggleston said population health policies remain central to China’s efforts to increase life expectancy and to bridge the gap between rural and urban areas.

Eggleston also noted that multiple factors beyond the availability of health care determine how long people live, and anticipates the research team will continue to explore the impacts of NCMS by extending the study to look at infants and youth.

Read the study (may require subscription) and view a related article on the Stanford Scope blog.

Design learning and journey maps are all the rage here at Stanford University and in Silicon Valley. So why not apply it to health systems to reduce diagnostic errors?

That’s what Stanford Health Policy’s Kathryn M. McDonald is trying to do: Map the journey of worrisome scenarios that keep clinicians up at night, and then plant design seeds that might just help those clinicians get back to sleep.

One of those real-world scenarios involves a preventable diagnostic error made as a high-risk condition unfolds across multiple visits to the doctor. Missed cancer diagnoses, for example, are the leading cause for paid medical malpractice claims in the ambulatory setting, with one in 20 patients experiencing potentially preventable diagnostic errors each year.

“For example, a patient who has a positive fecal blood test, but no follow-up colonoscopy within a reasonable period may experience a missed opportunity to detect and successfully treat colon cancer,” McDonald said.

McDonald and her team worked with San Francisco public health clinics that cater to low-income patients to investigate this key problem — missed diagnosis and prevention activities during outpatient care — then came up with design seeds to plant possible solutions.

She and her co-authors published their research in the journal Implementation Science. The project was conducted at the Ambulatory Safety Center for Innovation (ASCENT), a patient safety learning laboratory led by Dr. Urmimala Sarkar at University of California San Francisco, and funded by the federal Agency for Healthcare Research and Quality.

The team used a research design approach called “journey mapping,” a tool that tells the story of a customer’s experience through his own viewpoint. They constructed maps for each pathway used by doctors to monitor patients with sinister findings, starting with the initial diagnostic assessment during an initial clinic visit and continuing through ongoing follow-up visits.

“Whenever participants in the study verbalized elements of the pathway that were particularly vulnerable to error or poor monitoring, we marked the activity with a bullseye target, also referred to by clinicians as a ‘pain point,’” the authors wrote. “To our knowledge, this technique has seldom been applied to the ambulatory setting, and has not been targeted to clinic workflow efficiency or patient safety intervention development.”

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“A design seed gives the specs for what a solution needs to do,” said McDonald, who is the executive director of Stanford Health Policy’s Center for Health Policy and Center for Primary Care and Outcomes Research. “Once you know the vulnerabilities through journey mapping, you create all the design seeds that are tied to the problem, then the implementation stage becomes much more straightforward and more likely to assure that all the key goals are met.”

To test out this theory, McDonald’s team spent the last two years working with doctors, residents, nurse practitioners and registered nurses with the San Francisco Health Network. The publicly funded integrated health network operates under the auspices of the San Francisco Department of Public Health and includes 14 primary care clinics, as well as urgent and specialty care at Zuckerberg San Francisco General hospital.

“The health system serves many of the most medically and socially vulnerable patients in San Francisco,” the authors wrote in their research paper. “Like many safety-net systems and ambulatory practices, the health system does not have a comprehensive electronic health record system and struggles with information transfer as well as fragmentation of health information across over 50 electronic platforms.”

The health system had more than half a million outpatient visits last year by people who could not afford care. Patients at the network’s main clinics and hospital are diverse: 35 percent are Latino, 21 percent are white, another 21 percent are Asians, and 17 percent are African-American.

Only 1 percent of the network population has commercial insurance; 10 percent were uninsured; 57 percent were on Medi-Cal — California’s Medicaid program — 21 percent were on Medicare and the remaining 11 percent were covered by other, mostly public sources.

This type of ambulatory health care is complex, requiring constant tracking and reconciliation of individual patient activities, patient data, and the unique evolution of each clinical case.

"Human factors and industrial design methodologies have tremendous potential to help unravel these complexities and provide fundamental insights that can drive the development of novel solutions," said co-author George Su of the University of California San Francisco School of Medicine.

McDonald said that journey mapping helped frontline clinic members see their workflow for a specific task, which in this case was monitoring this diverse population for follow-up visits after a potentially sinister finding. The system challenge is population management of an ill-defined problem.

“Lots of ambulatory care work is done one patient interaction at a time, but robust monitoring requires a view from a higher plane,” she said in an interview. “Journey mapping makes the aerial view more tangible and realistic for clinic team input.”

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McDonald’s team selected high-risk cancer situations: incidentally discovered pulmonary nodules; monitoring for breast, colorectal and prostate cancers; and ear, nose and throat cancers. These high-risk cancers require recurring and timely follow-up care to assure intervention whenever the disease takes hold.

The team interviewed clinicians from each of five specialty clinics responsible for these high-risk patients in pulmonary medicine, breast cancer, gastroenterology, urology, and otolaryngology. They asked the frontline clinicians: “What keeps you up and night? And what are your clinical hunches about who might fall through the cracks?”

While the providers talked about the types of patients who become lost to follow-up visits, the researchers found, none of the clinics had a standardized and efficient method of quantifying how many patients were lost to follow-up care and, perhaps more importantly, why.

“Many other health networks share similar struggles with incomplete documentation and measuring the real-time scope of patient safety problems,” wrote McDonald and co-authors Sarkar, Su and Sarah Lisker of the University of California San Francisco School of Medicine; and Emily S. Patterson of Ohio State University College of Medicine.

“When a patient has a warning signal for a serious condition that has yet to materialize but may in the future, the ability of a clinical team to watch the patient closely over time hinges on incredible vigilance on the part of individual clinicians — hardly an ideal solution,” McDonald said.

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This is the crux of the problem, she said, and where so-called “design seeds” are planted.

“The design seeds lay the groundwork in a very specific fashion. Journey mapping and process tracing figure out the problem, in our case, vulnerabilities, and then the design seeds are the first-stage of the solution,” McDonald said. “It’s very user-focused, learning directly from those who are on the frontlines of the work, and making sure that the problem is specified in a way that allows for the developments of solutions that can scale more flexibly during implementation.”

The team identified 45 vulnerabilities within San Francisco’s publicly funded health clinics.

“Repeatedly, we heard that clinicians worry about properly tracking these patients, and are troubled by the significant personnel time required in carrying out patient-level monitoring activities without tools and organization approaches for population-level monitoring,” they wrote.

But even then, the team did not jump straight to solutions. That’s the next step.

The team will launch a pilot project to test possible solutions that will grow from the design seeds, such as whether new digital technology, workflow arrangements, and structured data collection could help find those patients lost in the cracks of an overloaded system.

“Such focused and potentially scalable work is particularly needed for patients who may be lost to follow-up in systems that are stretched for dollars and time,” the authors concluded. “Providers will often create informal workarounds in response to the lack of comprehensive and coordinated record-keeping systems, which can result in errors as well as redundant efforts.”

The ASCENT team is already implementing a monitoring solution informed by the journey mapping activities, in subspecialty care clinics at Zuckerberg San Francisco General, by testing technical and workflow models.

“We determined the need for a registry for high-risk patients in the otolaryngology clinic to help us monitor the entire process,” said Sarkar, a primary care physician and head of the ASCENT lab at UCSF. “This means the final diagnosis, workup and treatment planning, the actual treatment itself and then surveillance and follow-up.”

After going in for a routine procedure, a man ends up with a punctured lung and a medical emergency. A woman's surgery goes well until her stomach is stitched up with a sponge inside. Most of us feel safe going to the doctor, but the road to high-quality care was not straightforward. In this FSI World Class Podcast, Stanford Health Policy's Kathryn McDonald tells us how the safe, high-quality care we expect got where it is today and what we can do to maintain it. Kathryn McDonald is the Executive Director of the Center for Health Policy/Primary Care and Outcomes Research at Stanford University.

And in this Q&A posted on Medium, McDonald responds to the age-old question: How can we improve the quality of health care?

"One of the lead agencies that’s responsible for generating evidence and moving it into practice is the Agency for Healthcare Research and Quality (AHRQ). They’re under Health and Human Services. They have a major program called AHRQ’s Evidence Now aimed at improving heart health in America. Lots of people are on aspirin to prevent heart attacks, but there are also lots of people who could benefit from it who aren’t on it. They’re working with the health-care delivery system to figure out how to get patients who need to be on aspirin to use it. These are driven by reforms to make the delivery system accountable for patients’ health. If you can change behavior — either of patients or of physicians — you can save more lives."

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Stanford Health Policy’s newest faculty member, Joshua Salomon, believes that one urgent need in global health research is to improve forecasts of the patterns and trends that are the major causes of death and disease.

Salomon, who is leaving leaving his position as professor of global health at the Harvard T.H. Chan School of Public Health to join Stanford on Aug. 1, works on modeling of infectious and chronic diseases and their associated intervention strategies, as well as methods for economic evaluation of public health programs and ways to measure the global burden of disease.

And he looks at the potential impact and cost effectiveness of new health technologies.

“Projections of future trends in health are crucial to formulating policy,” said Salomon, who has a PhD from Harvard. “To think strategically about the technologies and policies that would make the biggest impact on health over the next 20 to 50 years, we really need to start by understanding the range of likely trends in major health challenges over the coming decades.”

Stanford, he said, offers him a “rich collaborative environment” to better learn from advances in forecasting across a range of other disciplines, such as economics, political science, and environmental science.

“With a better picture of what the world is likely to look like over the next 50 years — and what are going to be the most pressing health problems — we can invest wisely and put ourselves in a position to respond more effectively.”

Salomon is also the director of the Prevention Policy Modeling Lab, which is funded by a five-year award from the Centers for Disease Control and Prevention. The consortium represents the collaborative research of experts from Massachusetts General Hospital, Boston Medical Center, Dana Farber Cancer Institute, Yale School of Public Health, Brown University School of Public Health, and the Massachusetts Department of Public Health and.

He will continue directing the lab from Stanford and intends to bring in new research threads from his colleagues here on the Farm. The lab works on a wide range of projects dealing with policy analysis for hepatitis, sexually transmitted infections and diseases such as HIV, and tuberculosis.

“It’s a rewarding grant for me to work on because, unlike a lot of modeling projects, the work that we do really starts from urgent public health questions that policymakers have,” he said. “All of the questions that we are working on are questions that originated directly from discussions with CDC and other public health partners.”

With Salomon’s move to Stanford, the university gains a dynamic duo.

Grace Lee joins Stanford as the Associate Chief Medical Officer at Lucile Packard Children's Hospital in the fall, 2017.

His wife, Grace Lee, MD, MPH, joins in the fall as the Associate Chief Medical Officer at Lucile Packard Children’s Hospital. As a professor of population medicine at Harvard Pilgrim Health Care Institute & Harvard Medical School, Lee has led research in vaccine safety in the FDA-funded Post-licensure Rapid Immunization Safety Monitoring (PRISM) program and the CDC-funded Vaccine Safety Datalink, which monitors the safety of vaccines and studies rare and adverse reactions from immunizations.

She has also examined the impact of financial penalties on rates of healthcare-associated infections, as the principal investigator of an AHRQ-funded study, as well as developed novel surveillance definitions for ventilator-related events in neonates and children.

While at Stanford, Lee said, she intends “to find opportunities to enhance the learning health system approach to improve patient outcomes and population health.”

Salomon has spent his entire career as a collaborator on the Global Burden of Disease project, the world’s most comprehensive epidemiological study commissioned by the World Bank in 1990, which tracks mortality and morbidity from major diseases, injuries and risks factors.

“The study has made a major contribution to global public health because before this study we just didn’t have a comprehensive, systematic understanding of the things that cause death and disability in low- and middle-income countries. But now we do,” he said. “It’s hugely ambitious and very sweeping in scope — and a lot of my work is around providing the evidence we need to inform policy.”

Much of Salomon’s work is global in nature. He’s most recently focused on older adults in one rural South African community, which has a high prevalence of HIV and one of the world’s highest levels of hypertension. His research there aims to inform urgent prevention initiatives tailored to older adults where HIV and cardiovascular risks are moderate or high, as in similar communities in sub-Saharan Africa.

“People don’t expect a high level of ongoing HIV transmission in older adults,” he said. “The double burden that we find, with a very high level of HIV, as well as the high prevalence of diabetes and heart disease, creates enormous strains on the health-care system.”