Clinical research is no longer limited to finding the next wonder drug, developing a new device, or discovering a genetic mutation. More than ever before, caregivers are engaged in the scientific study of healthcare itself: measuring patient satisfaction, exploring efficiency, and investigating how to improve safety. It’s called health services research, and it is transforming medicine.
It was a perfectly routine exam: Internist Daniel Stone, MD, was finishing up with his 68-year-old patient when she asked for a refill of her antianxiety medication. Five years earlier, Dr. Stone might simply have asked how the drug was working for her, scribbled out the prescription refill, and thought no more of it. On that day, however, he entered the order into Cedars-Sinai’s electronic medical records system and an alert popped up: Recent research indicated that benzodiazepines — a class of drugs that includes remedies for anxiety and insomnia — increased the risk of falling, hip fracture, and hospitalization in older patients and were no longer recommended.
“When you’re seeing a lot of patients every day, it’s easy to gloss over something simple like a refill,” says Dr. Stone, medical director of the Cedars-Sinai Medical Group. “This tool is a catalyst for smarter care.”
The tool in question is a clinical support platform called Choosing Wisely, an initiative of the American Board of Internal Medicine Foundation. Much like blind-spot monitors in sophisticated cars, Choosing Wisely offers timely cautions and guidance to caregivers as they navigate through patient visits and procedures. With the support of Consumer Reports, the information is available in easy-to-understand materials. Review of this information helps the patient and his or her physician determine appropriate treatment based on trusted data. It also helps them assess whether certain tests and procedures may be ineffective, unnecessary, or needlessly risky, given the circumstances. At Cedars-Sinai, the reduction in benzodiazepine use alone is projected to lead to 22 fewer fall-related injuries, three fewer hospitalizations, and two fewer deaths from falls this year.
After considering the alert on his screen, Dr. Stone explained the potential dangers of benzodiazepines to his patient. “Some patients will accept these risks and decide to keep using their medication, while others will ask for alternatives,” he says. This particular patient was happy to stop taking it and grateful for the extra, personalized attention.
Choosing Wisely exemplifies a trend that has shaken up traditional models of medical research and clinical care in the U.S. The timeworn image of biomedical research as just involving lone investigators hunched over collections of tissue samples and beakers has been superseded. No longer confined to the laboratory, scientific methodology now sees researchers bringing studies to kitchen tables and birthing rooms, health fairs, and barbershops.
These days, the science of healthcare extends far beyond the realms of disease prevention and treatment. Patient satisfaction is measured minutely. Surgical efficiency and rates of cesarean sections are studied as closely as traditional evaluations like medication side effects and survival rates. And hospitals such as Cedars-Sinai are leveraging new methodologies to ensure the best possible care is provided to as many segments of the community as possible.
The appropriate use of scientific analysis in all aspects of patient care has a positive impact on safety and also helps to lower costs and improve efficiency — vital considerations at a time when the American healthcare system is shifting toward greater affordability. But this advance adds up to much more than dollars and cents. It’s leading to something priceless to patients: the individualized application of data and knowledge, and a novel brand of medicine that prioritizes experience as well as biology. As research moves past the confines of the lab, so does medicine’s capacity for innovation — auguring the dawn of a new kind of care that is more precise, patient-focused, and personalized.
A sea change has swept the field of medical research during recent years with the publication of several landmark papers. One major report by the Institute of Medicine revealed that medical errors cause a startling 44,000–98,000 deaths per year. “That study had a huge impact because this was not a bunch of renegade doctors but one of the most prestigious medical organizations on the planet saying there was a real opportunity to improve care and reduce patient mortality,” says Scott Weingarten, MD, senior vice president and chief clinical transformation officer at Cedars-Sinai. The revelation raised an alarm among physicians and healthcare industry leaders.
Two other key papers in The New England Journal of Medicine showed that patients received treatment in line with the latest and best scientific evidence only about half the time.
Why was this happening? One reason is the sheer volume of medical research publications: Some 800,000 new scientific articles are added to the Library of Congress each year. “That’s a paper published every 26 seconds, plus thousands of practice guidelines,” Dr. Weingarten points out. PubMed, the go-to source for biomedical literature, adds 500,000 new records annually. PubMed comprises a whopping 24 million citations, and its collection doubles every 13 years. As Dr. Weingarten says, “It is not humanly possible for any physician, no matter how good, to keep up.”
This means that even if a physician is a deeply caring genius who devotes endless hours to reading scientific papers, it is still possible that, at some point, the patient might not get the right care at the right time.
Practices had to change, and that shift came in the form of evidencebased medicine (EBM), which integrates clinical expertise with the most up-to-date medical research findings to make conscientious, judicious decisions for the care of individual patients.
The use of systematic analysis is not confined to science — the approach also drives countless decisions in marketing and advertising, product design, and even sports. The bestselling book and feature film Moneyball celebrates Billy Beane, the Oakland Athletics manager who employed rigorous statistical analysis instead of the conventional wisdom most teams used to run their game. He adopted a new set of metrics for baseball that were better predictors of success and transformed one of the most revenue-challenged clubs into one of the most competitive, cost-effective teams in the sport.
The appropriate use of scientific analysis in all aspects of patient care has a positive impact on safety and also helps lower costs and improve efficiency.
On the face of it, EBM sounds like what good doctors have been doing all along: studying evidence to come up with the right answer for a patient. In fact it upends an age-old tradition that relies heavily on a single physician’s judgment and training, just like a talent scout for a baseball team would traditionally base his assessment of a young player on a narrow set of observations. Evidence-based practice filters and assesses swaths of clinical and scientific data, allowing doctors to reach decisions using a combination of the most powerful research to date, their expert intuition, and a particular patient’s idiosyncrasies and symptoms. The methodology has been around since the 1990s but has gained prominence with the growing gap between the amount of information available and the time demands of clinical practice.
“The human element remains vitally important,” says Dr. Weingarten, who led the implementation of Choosing Wisely at Cedars-Sinai. “In that program, for example, the alert is used to prompt an informed discussion between doctor and patient, not make the decision.”
A financial catalyst also spurred the use of this approach in healthcare. Annual health costs for a typical family of four covered by an average employersponsored health plan will top $23,000 this year. The Affordable Care Act and Medicare are pushing all health systems to be more efficient in an effort to stem ballooning costs. The Oakland A’s do-more-with-less-approach to baseball now applies to a new, value-based healthcare model that pursues quality at affordable rates.
While reducing errors and inefficiencies does lower costs, Dr. Weingarten notes, “We never take a money-first approach. Our efforts focus on achieving the best possible clinical outcomes and quality of care for all of our patients.”
Bradley Rosen, MD, who deals with budgets on a daily basis as Cedars-Sinai’s director of care transitions and complex medical management, adds: “It’s important to remember that quality outcomes and saving money are not mutually exclusive. If we keep people healthy, it costs less and overall value increases.”
The result is that today, think tanks, hospitals, and public health organizations are all focusing on efficiencies, safety, and the process of healthcare delivery. “Many have recognized that innovations in the delivery of medical care can save as many or more lives as the discovery of various new drugs, devices, or genes,” says Dr. Weingarten. Furthermore he believes that “future Nobel prizes will likely be awarded for innovative discoveries that save lives, reduce illness in communities, and improve quality of life — all while lowering healthcare costs.”
The idea of using algorithms to improve medical decisions and patient satisfaction may leave a lot of people scratching their heads. But the model has the same humble goal that good medicine has always had: to find better ways to care for patients and cure diseases. “We do this to deliver the right care to the right people in the right place at the right time,” says Cedars-Sinai Vice President and Chief Nursing Officer Linda Burnes Bolton, DrPH, RN.
When patient experience is a priority, the questions asked during scientific inquiry are no longer confined to the realm of “Is this antibiotic working?” They include queries such as “Does this new mother’s birth plan include immediate skin-to-skin contact?” and “Who is going to make sure this elderly man, who lives alone, remembers to take his medication?”
“Many have recognized that innovations in the delivery of medical care can save as many or more lives as the discovery of various new drugs, devices, or genes.”
— Dr. Scott Weingarten
“There are things that no one else can say about your healthcare,” says Robin Weinick, PhD, associate director and senior social scientist at RAND Health. “How closely do you follow your physician’s advice? How often does your doctor return your calls? Do you refill your medications?”
To answer these questions, providers and investigators need to know how patients are faring in their homes, both before they get sick and after they leave the hospital. “Ninety-nine percent of an individual’s experience with illness or injury happens nowhere near a physician,” says Brennan, MD, director of Health Services Research at Cedars-Sinai. “To capture the true nature of disease and find solutions, we have to reach patients where they live.”
Dr. Spiegel’s team of investigators is transforming the way patients, doctors, and hospitals communicate through innovations such as wearable biosensors that track patients’ vital signs at home and transmit their data to electronic medical records. The researchers also have developed a computer program that allows patients to explain their medical histories online. The platform is “smart,” asking relevant follow-up questions and drawing out information that leads to a robust dialogue between doctor and patient.
Dr. Weinick, whose own work on healthcare quality concerns the rigorous measurement of patient experiences, says: “There’s a movement to get patients seriously involved in how research questions are asked and answered. That will lead us to better outcomes.”
Along with human diversity comes great complexity, because each individual lives at the nexus of experience, psychology, and biology. And with revolutions in fields such as genomics, every gene, protein, and bacterium involved in human health can be investigated to a degree unimaginable even a few years ago. No individual researcher, no matter how dedicated, can analyze the resultant mountains of data in the traditional way.
The gap between the swelling mass of information and human computational capacity has led to more sophisticated data-dissecting tools. These tools helped map the human genome more than a decade ago and are now being used to chart the microbiome — the trillions of microorganisms that inhabit our bodies. They are also helping researchers map the human experience.
Dr. Brennan Spiegel is using Twitter to conduct a comprehensive study on how opioid pain medications affect individuals. His team filtered that mass of messages down to about 10,000 relevant to their research on the gastrointestinal side effects of such drugs.
Dr. Spiegel, who leads the new Center for Outcomes Research and Education at Cedars-Sinai, is using Twitter to conduct a comprehensive study assessing how opioid pain medications affect individuals. In the course of a few days, his team gathered 200,000 messages from around the globe and is busy categorizing them. The initial round of data included anything people were sharing about the medications on Twitter and other health-related e-forums. Dr. Spiegel’s team filtered that mass of messages down to about 10,000 that are relevant to their research on the gastrointestinal side effects of drugs.
“We know from clinical trials in highly controlled environments what side effects a patient might experience,” he says, “but when we start with 200,000 bits of information, we get into the world of big data.”
Mining big data allows Dr. Spiegel to identify trends. “Computer algorithms, applied correctly, can help us find otherwise undetectable signals in the noise,” he explains. “We might identify a side effect so rare that we haven’t seen it in the clinic. Or we might see how patients cope with side effects by modifying their dosage. We can use those results to form a hypothesis that ends up revealing new solutions for people struggling with opioids.”
As scientists like Dr. Spiegel cast an ever-widening net, their research serves patients in the most intimate way possible. His “signals in the noise” are unique traits that are shared by small, scattered groups of individuals. As more of those traits are discovered and understood, medicine can offer personal and precise solutions to more people. Thought leaders like Dr. Weingarten envision intensely personalized healthcare. “Your patient chart will still include your family history, medications, and all the usual information,” he says, “But down the road, we are also going to be able to go beyond that to include information related to a patient’s genomics and lifestyle to make sure that we provide cost-effective, personalized, and effective care for each patient.”
While we all understand the need for costeffectiveness, not everyone in the medical community is on board with an emphasis on patient experience or big data. A certain amount of skepticism remains, and some physicians prefer to rely only on their years of experience and wellhoned intuition.
In the hopeful future fueled by the research revolution, medicine will address individual patients’ experiences to improve the care of their individual health, while exploiting a rich new universe of data and technology.
And while big data is making an impact everywhere from marketing to medicine, the science is still in its infancy. Dr. Spiegel acknowledges that there is a backlash. “Big data is often considered to be dirty data, and that makes the scientists in us twitchy. We like data that is cultivated, clean, and whose origin we know — but unfortunately that’s not reality.”
He agrees with the general consensus that data alone cannot solve problems. “There is so much hype about how modern technologies can improve healthcare, but few academic hospitals are rigorously studying how to make it happen the way Cedars-Sinai is doing.”
The biggest caveat of all might be that no piece of technology or novel program, no matter how brilliant, can heal every ill. “Everyone wants to live forever with the highest possible quality of life,” says Dr. Rosen. “That leads to challenges with expectation management. No one’s gotten out of life alive yet, of course. But as long as they are our patients, we will do everything we can to help them.”
In the hopeful future fueled by the research revolution, medicine will address individual patients’ experiences to improve the care of their physical health, while exploiting a rich new universe of data and technology.
Physician-scientists like Dr. Spiegel will continue to harness the endless river of incoming data from journals, clinical trials, social media, and electronic medical records — and strive to present it in an evocative and useful way to caregivers. “We will home in on the authentic, unique health story of each person,” he says. “How well we do for each individual will eventually determine the wellbeing of the entire population.”
The change is already underway with programs such as Cedars-Sinai’s Choosing Wisely. Dr. Stone, the physician with the 68-year-old patient and the antianxiety prescription, notes that the best alert he gets from the system is the one he never has to see. “These notifications become part of the consciousness of the physician because they transform the way you think,” he explains. “The technology, in the end, makes you a wiser doctor — and your patient walks into the world fully informed and healthier.”