Hey Doc, Got a Patient for My Trial?

One of the really great things about working in a large academic medical center is the amazing depth and breadth of research that is going on across our institution.

We have the advantage of some of the world’s leading experts across almost every imaginable medical specialty helping us take care of our patients and, as a byproduct of that, many of them are doing research at the forefront of their fields to try to push the envelope of discovery and innovate the care of patients as we move forward in the 21st century. And our own clinician-educators here in our practice are doing cutting edge research on patient education, practice transformation, technology innovations, and more.

One of the challenges for those of us here in primary care adult medicine is that sometimes there’s so much research going on, it’s hard to keep track of which studies researchers are doing and how we can help.

Many Requests

As the medical director of our practice, I get emails every day from serious well-intentioned and eager researchers who are looking for patients to enroll in clinical trials small and large. And we have an endless stream of researchers come to our faculty meetings to give presentations on their work, and we have asked them to do this in order to be allowed to recruit study patients in our practice.

We want to ensure that it is appropriate for our patients to be recruited by them, that we think this is useful and important research, and that our patients won’t be too overwhelmed by being approached for these studies.

Beyond the basic science research that goes on in labs across the street lie the clinical research projects that our cardiologists, endocrinologists, nephrologists, dermatologists, ophthalmologists, and surgeons of every type are looking to do to try and further their specific fields (as well as their academic careers).

We have researchers looking at all aspects of care, from primary pharmaceutical research to studies with a more sociological bent examining how our patients experience the healthcare system and how we can help improve it.

These researchers present their study to us, give a little background on their field, discuss what led them to decide to study this particular question, and then go through the nuts and bolts of the study, ultimately getting to the inclusion and exclusion criteria.

At the end, they tell us that they’re looking for 10 to 20 patients for a focus group, 100 to 200 for a new treatment intervention, or 1000 to 2000 for a major drug trial, and they ask us if it’s okay for them to recruit our patients. If we’ve done a good job of screening these researchers in advance, almost without exception most of the clinicians in our group give approval for their patients to be recruited for the studies.

Out of Sight, Out of Mind

But then the hard part comes. When you’re sitting in a conference room and someone says, “Do you have any patients with high blood pressure who are noncompliant with their medications who have challenges in health literacy that may be interfering with their ability to comply with medical treatment?,” we almost always say, “Sure, I can think of a dozen of those.”

And when researchers want to enroll our patients in large national trials studying precision medicine or social barriers to health or healthcare disparities, we say “Bring it on.”

But once the faculty talk is finished, we go back to our busy days seeing patients, and more often than not these studies drift away from the forefront of our attention and the details get a little blurry. Out of sight, out of mind.

While I’m seeing patients in my jammed schedule through the afternoon, what’s going to help me remember that this particular patient might be eligible for that hypertension study, and what about this one with end-stage renal disease awaiting transplant for that research study that some nephrologist talked to us about last month?

Lots of research studies, lots of patients, lots of potential enrollees and opportunities to align the right patient with the right study, but for the most part my brain is too filled up with other things to remember that particular study at the moment that the perfect patient is sitting there in front of me.

An EHR Solution?

We’re hoping that we can use the sophistication of our electronic health record (EHR) to align the study in need of patients with the just-right patient being seen in our practice that day.

We’ve started to build a template to put in all of the different research studies that are being done, and to figure out a way to query the inclusion and exclusion criteria to the schedule of patients being seen in the practice that day, and thus generate a report to the study coordinators to tell them that yes, Mrs. Jones and Mr. Smith are coming to see Dr. Pelzman today, and they may be perfect for your study.

After that, if all works well, I’ll get a pop-up alert that tells me that my next patient may be eligible for the such-and-such study, and can I mention it to them while I’m seeing them, or is it okay for them to be approached by the study’s research coordinator in advance or after my appointment.

Perhaps the EHR will be even be able to send patients an email telling them that they may be eligible for a particular study, and give them a heads up that someone may approach them.

In the end, we hope that this will create a system that better captures the right patient for the right study, without burdening the providers to try and remember all the studies that are going on out there in the ether and trying to match this patient with that researcher.

As we all know, research is not designed to specifically benefit the patient who has agreed to participate in the research study, but to inform future patients who share some attributes with them, to try and improve the lot of those people off in the future. But for the most part, we’ve seen that our patients relish the idea of participating in research, and readily join in.

They join focus groups to tell us about their barriers to health and how social inequities affect them. They tell researchers about the challenges they face across all spectrums of care, be it access to primary care, coordination of care, medication errors, or excessive testing.

We have to remember that all of this academic research stands on the shoulders of those patients who agree to participate, to not only help that researcher get an academic promotion, but also move their chosen field of healthcare inquiry forward. Building a better research infrastructure using the technology we have at hand can help all of this happen in a more efficient fashion.

The search for better research continues.

https://bit.ly/2n8Jxf0

Dimon: Healthcare initiative may start small, like Amazon did with books

J.P. Morgan Chase’s CEO Jamie Dimon said Monday that his partnership with Jeff Bezos and Warren Buffett to improve health care for employees will likely start small, akin to Amazon’s small-scale operation during its first few years.

“This is an absolute critical issue and all of us have a long-term view and we’ve been through the amount of money spent on fraud, administration, end-of-life, the misuse of drugs,” and others, Dimon told CNBC’s Wilfred Frost. “I’ll remind people that Jeff Bezos, when he started Amazon, he might have had visions about the ‘everything store,’ but he started with books. And he spent 10 years getting books right.”

“So we may spent a bunch of time getting one piece of it right, and testing various things to see what works,” he added.

Mark Urban | CNBC

Jamie Dimon, CEO of JP Morgan Chase.

Dimon, 62, is the longest-tenured of CEOs leading a major U.S. bank. Amazon, Berkshire Hathaway, and JPMorgan Chaseannounced earlier this year a partnership to cut health-care costs and improve services for their U.S. employees.

The companies, which employ more than 1.1 million workers combined, will launch an independent operation that’s intended to be free from profit-making incentives. The chief executive added that the joint venture upset some of J.P. Morgan’s clients, but said that if some chose to leave as a result of the initiative “so be it.”

The new company’s goal at first will be to target technology solutions to simplify the health-care system.

“I want to do a better job, and we’re going to put more brainpower, more capability to figure out how we can make you healthier and happier with better satisfaction,” Dimon added, noting that approximately 20 percent of U.S. gross domestic product is spent on health care. “We’re totally in-line with Jeff Bezos and Warren Buffett – Amazon and Berkshire.”

The business trio tapped renowned surgeon and author Atul Gawande in June to lead the joint venture in the hopes to slash cost. Gawande, an outspoken critic of the industry’s medical practices, has argued against prolonging a poor quality of life for the elderly and terminally ill, saying health care institutions often deprive patients of independence and quality of life.

“We think together we have the right people, a long-term view, we’re not profit-seeking, and that we can do what we’re doing a lot better,” Dimon said. “We don’t expect progress in the immediate future – like a year or two – but if we come up with some great stuff, we’re going to share it with everybody.”

https://cnb.cx/2KeqqsS

Smoking ban in public housing might make quitting easier

A new U.S. ban on smoking in public housing may make it easier for low-income smokers to quit, a new study suggests.

This week, the U.S. Department of Housing and Urban Development (HUD) implemented a ban on cigarettes, cigars, and pipes inside apartments, common areas and outdoor spaces within 25 feet of public housing properties; it doesn’t cover e-cigarettes.

While the primary goal of the ban is to improve indoor air quality and reduce residents’ exposure to secondhand smoke, it may also help low-income smokers be more successful at quitting, researchers note in PLOS One.

The researchers analyzed data from a nationwide survey asking participants about their smoking habits, whether smoking was allowed in their homes, and whether they had tried or succeeded in quitting over a 10-year period from 2002 to 2011. They also looked at other factors that can impact cessation like income and education.

Affluent smokers were almost twice as likely to succeed at quitting for at least 30 days as low-income smokers, the study found.

People with smoke-free homes were 60 percent more likely to quit smoking for at least 30 days than people without this prohibition, the study also found. However, the prevalence of smoke-free homes was 33 percent lower among low-income people than among more affluent individuals.

“Reducing consumption is a predictor of successful quitting,” said lead study author Dr. Maya Vijayaraghavan of the University of California, San Francisco.

“The gap in cessation outcomes between lower and higher income individuals could be reduced by up to 36 percent if more lower income individuals adopted smoke-free homes,” Vijayaraghavan said by email. “This is substantial reduction in the cessation gap at the population level.”

Smoke-free homes might aid cessation by making it harder for smokers to light up whenever they like, Vijayaraghavan said. Smokers might also cut back on smoking because it’s less convenient, and then cutting back might in turn make it easier to quit.

Over the study period, as more people across the country began to live in smoke-free homes, more people quit smoking for more than a month, an early indicator of successful quitting. The smokers who didn’t successfully quit consumed fewer cigarettes.

The researchers found no difference over the study period in how often U.S. smokers tried to quit, suggesting that other factors, such as living in smoke-free homes or stricter state tobacco control policies, explained the increase in smoking cessation.

The study wasn’t a controlled experiment designed to prove whether or how smoke-free homes might directly cause more people to stop smoking.

Even so, the results add to a large body of evidence suggesting that smoke-free housing can make it easier for people to quit, said Judith Prochaska, a researcher at Stanford University in California who wasn’t involved in the study.

“Smoke-free housing makes it easier for people to quit because it removes cues that trigger cravings to use the drug (e.g., seeing and smelling a cigarette, seeing lighters, ashtrays, cigarette packs), and it removes exposure to second and thirdhand smoke,” Prochaska said by email. Both inhaled secondhand smoke and thirdhand smoke left on surfaces like carpets and drapes both contain nicotine as well as carcinogens, Prochaska noted.

“Seeing people smoking on the streets or in parks also can be cues that trigger cravings, but they are more easily avoided than smoking in one’s residence,” Prochaska said. “No amount of ventilation and filtration has been found to effectively remove smoke exposure in interior environments.”

Smoke-free housing alone may not be enough to help many people quit, said Dr. Carlos Roberto Jaen of the University of Texas Health Science Center in San Antonio.

“These smoke-free housing policies need to be supported with cessation support in terms of cessation aids – for example promotion of tobacco cessation helplines or access to effective medications,” Jaen, who wasn’t involved the study, said by email.

SOURCE: bit.ly/2KrTLjM PLOS One, online July 27, 2018.

https://reut.rs/2OExL8N

China to add more cancer drugs to reimbursement list

China plans to add a range of cancer drugs to medicines eligible for reimbursement from the government, the official Xinhua news agency said on Saturday, adding that negotiations on pricing with manufacturers should be finished by end-September.

China’s cancer rates have been soaring, driven by growing numbers of people in their sixties, heavy smoking among men and exposure to pollution.

The drugs under discussion treat blood cancers and solid tumors, including colorectal cancer, renal cell carcinoma, lymphoma and chronic myelogenous leukaemia, according to Xinhua.

The news comes after a low-budget Chinese movie released earlier this year told a story about a leukaemia patient who turns to smuggling cheap cancer drugs from India.

The tale struck a chord with Internet users and even the country’s leaders, spotlighting national anxieties about unaffordable hospital care.

https://reut.rs/2AGrBlw

Provider consolidation outpacing payer in most of US

• As the healthcare industry continues to consolidate, greater regulatory scrutiny is needed to detect anticompetitive behaviors and protect consumers and employers from high prices and premiums, according to a new analysis by The Commonwealth Fund.
• To show how market concentration varies across the U.S., the researchers looked at concentration of providers and payers for each metropolitan statistical area in 2016. Markets were classified as unconcentrated, moderately concentrated, highly concentrated or super concentrated.
• For providers, 47.1% of MSAs were highly concentrated and 43% were super concentrated. By contrast, 54.5% of MSAs had highly concentrated insurance markets, while 36.9% were moderately concentrated.

Overall, provider concentration was greater than that of insurers in 58.4% of MSAs. Payers had the edge in just 5.8% of the studied areas.

Concentrated markets are bad for payers and patients. Yet even when payers have more negotiating power, they don’t always pass the savings along to their members. Regulators need to take steps to ensure consumers reap some of the benefits of consolidation.

The need for scrutiny will only increase as M&A activity continues to ramp up in the industry. Some research has shown mergers can drive up prices for patients, leading lawmakers to keep a close eye on deals in their area. In Massachusetts, the attorney general has raised skepticism of the proposed merger between Beth Israel Deaconess Medical Center and Lahey Health.

According to a recent analysis of healthcare M&A’s impact in California, high concentration in some markets is pushing up prices for hospitals, physician services and Affordable Care Act premiums.

In northern California, where concentration is more prevalent, inpatient prices and outpatient prices were 70% higher and between 17% and 55% higher, respectively, compared with less-concentrated southern California. ACA premiums were 35% higher in the north than in the south. The authors urged state and local regulators and lawmakers to take action.

The new findings have similar policy implications. More regulatory scrutiny is needed at both the state and federal level, the researchers say, noting regulators can use the information to determine whether new consumer protection policies are needed.

For example, more populous MSAs may exhibit lower concentration levels because the effect is spread over more than one market. If markets are highly or super concentrated, there may be other competitive factors that can ease potentially negative effects. “These might include whether it is easy for competitors to enter a market or if there are economies of scale that might lead to lower costs,” the study says.

The researchers note that larger, more integrated and financially robust providers could potentially introduce changes in diagnosis and treatment that improve quality while reducing costs.

https://bit.ly/2LRFwJO

Standards institute offers ‘how to’ for securing EHRs on mobile devices

• With smartphones and tablets becoming ubiquitous in healthcare, the National Institute of Standards and Technology has issued a “how-to” guide aimed at helping providers secure EHRs on mobile devices.
• The guide provides a simulated solution developed by NIST’s National Cybersecurity Center of Excellence using commercially available products. The scenario involves interactions among mobile devices and an EHR system that is supported by an organization’s IT infrastructure.
• NIST hopes people will use the guide to implement relevant standards and best practices for cybersecurity and HIPAA compliance.

Cybersecurity is becoming increasingly important as mobile devices are incorporated into all levels of care and hospitals and practices consider policies like bring-your-own-device, or BYOD.

In a 2017 Spõk survey, 71% of clinicians reported their hospitals permits some type of BYOD use, up from 58% in 2016. In the same survey, 65% of physicians and 41% of nurses conceded they use personal devices despite hospital policy against such use.

Much mobile device use centers around clinical care teams. In fact, Spy Glass Consulting found nine in 10 hospitals are investing in smartphones and secure mobile communications to drive clinical transformation. In a JAMF survey, 91% of healthcare IT leaders said they would benefit from an enterprise-wide mobile device initiative.

But ensuring the security of personal health information on mobile devices can be tricky. Mobile devices should be part of an organization’s overall governance program and should include issues like BYOD and what people can download on a flash drive, Kathy Downing, director of practice excellence and senior director at the American Health Information Management Association, told Healthcare Dive earlier this year.

“We see so many breaches when somebody has downloaded something on a flash drive and the flash drive goes missing,” she said.

The NIST guide:

• Maps security characteristics to recognized standards and best practices.
• Provides a detailed architecture and capabilities to enhance security controls.
• Automates configuration of security controls for ease of use.
• Discusses in-house and outsourced implementation.
• Shows how security personnel can recreate the simulation design in whole or in part.

The guide also covers issues such as audit controls and monitoring, device integrity, user authentication and transmission security.

https://bit.ly/2M5Iuux

Sticker prices in drug ads gets closer with bipartisan backing in Senate

Think President Donald Trump’s proposal to slap price tags on drug advertising is all talk and no action? Think again. Over the past couple of weeks, the idea has gained steam—and bipartisan backing, including from Democrats often critical of the president. So much so, in fact, that a bill containing the provision could see a Senate vote this week.

Last week, Sens. Dick Durbin, D-Ill., and Chuck Grassley, R-Iowa, proposed funding-bill amendments that would require pharma companies to put drug pricing in their ads. On Monday, the effort picked up major support with Sens. Kirsten Gillibrand, D-N.Y.; Sherrod Brown, D-Ohio; and Angus King, I-Maine, signing on as co-sponsors. Sen. Richard Blumenthal, D-Conn., joined on Tuesday. The proposed mandate was first introduced in May as part of the Trump Administration’s drug-pricing “blueprint,” a slate of proposals officials say will bring down drug prices.

The senators who’ve put that idea into legislation bring veteran political experience, clout and outspoken views. Gillibrand, who is said to have White House aspirations, often speaks out against Trump policies she disagrees with. She’s also an emerging voice in the political pushback on pharma pricing; she recently introduced a bill designed to stop price gouging on prescription drugs and has co-sponsored at least four others this year that would improve drug access and affordability.

She—along with Durbin, King and Brown—also sent letters to eight Big Pharma companies in May asking them to voluntarily add drug prices to their direct-to-consumer ads. Gillibrand, Brown and King did not respond to requests for comment for this story.

The Republican-driven H.R. 6147 appropriations bill, on which the Durbin-Grassley amendment is proposed, passed the House on July 20 and is expected to get a Senate vote this week. The fate of the drug ad requirement won’t be known until then. However, the widening dual-party support can’t be seen as a good sign for the industry.

Pharma industry lobbying group PhRMA remains opposed. Holly Campbell, PhRMA deputy vice president for public affairs, said via email that the association has publicly noted that disclosing list prices won’t benefit patients. List prices aren’t usually the prices insurers pay, and given the wide variety of drug-coverage plans, wouldn’t be good indicators of what patients would end up paying at the pharmacy, PhRMA has said.

As part of PhRMA’s recently filed 130-page reply to HHS’ request for comment on its drug pricing blueprint, the trade group wrote that including list prices might scare patients off and deter them from talking to a doctor about getting a treatment.

“In addition to the policy concerns, any consideration of requiring disclosure of list prices in DTC ads must be squared with FDA’s statutory authority and First Amendment restrictions against compelled speech,” the PhRMA document stated. “We do not believe that FDA currently has the statutory authority to impose such a requirement or that such a requirement would be constitutional.”

https://bit.ly/2OCl26v