NASHVILLE -- Cancer care physicians and providers are not discussing sexual side effects of treatment with their patients, a researcher reported here.
A 19-item survey was distributed to 88 oncology physicians and advanced practice providers (APP), of whom just 13 responded, according to Justin Dubin, MD of the University of Miami Miller School of Medicine.Among the nine oncologists and four APPs who did respond, 30.8% said they often or always discussed sexual health with their patients.
But almost half (46.2%) of responding providers said they rarely or never referred their patients to a specialist trained in sexual health, Dubin and colleagues reported at the Sexual Medicine Society of North America (SMSNA) fall meeting.
Also, more than half (53.8%) reported never receiving training in male erectile dysfunction, while 61.5% said they had never received training in male ejaculatory or orgasmic disorders.
61.5% reported that they had never received training in female sexual disorders related to orgasm or libido.
Sexual side effects are common following treatment for prostate, bladder, colon and other cancers. The study was designed to explore attitudes about providing sexual health information, training in the topic, and barriers to discussing sexual health with their patients with cancer.
"As sexual health experts we are interested in keeping this topic on the agenda," Dubin said. "Unfortunately, the limited data we have shows that sexual health is infrequently discussed by cancer providers. If we are going to improve the sexual health of cancer patients, we really need to start focusing on educating and training these providers."
Co-author Bruce Kava, MD, also of the University of Miami, noted that the low survey response said as much about cancer providers' reluctance to discuss sexual health, as the responses themselves.
"Not only are they not talking to their patients (about sexual health), they didn't want to talk to you about not talking to their patients," he said.
The two barriers to discussing sexual health most often sited by the providers were limited time and lack of training.
Kava said any outreach to oncologists should be simple, direct, and limited to three key points: ask, tell, refer.
"(Oncology providers) have no patience for this stuff. They are very pressed for time." he said. The message should be that the providers should ask their patients about sexual health issues, tell them there are solutions, and refer them to a sexual health specialist, he added.
In a separate SMSNA talk, Carolyn Salter, MD, of Memorial Sloan-Kettering Cancer Center in New York City, said patients and their partners are often unaware of the sexual side effects they may experience related to their cancer treatments.
"Many of the women and their partners were not informed about sexual side effects before treatment, or, if they were informed, they didn't retain to fully understand it," she told MedPage Today.
As a result, many of the women expressed guilt about not being fully informed or exploring other treatment options with their partner, and many were reluctant to discuss treatment-related sexual dysfunction within the relationship, Salter said.
"The issue became the elephant in the room for a lot of couples, and the women were scared to bring it up for fear of making it worse," she said.
Dubin also presented survey results exploring sexual health among adolescent and young adult male cancer patients.
A total of 72 men (ages 18-39) who were scheduled to begin, undergoing, or had recently completed cancer treatments were asked to complete the sexual health surveys International Index of Erectile Function (IIEF-6) and the Masturbation Erection Index (MEI).
A total of 30.6% responded, and 63.3% reported being in a sexual relationship with a partner. Almost half of the men who completed the surveys reported little difficulty achieving or maintaining an erection during intercourse and masturbation, despite their cancer treatment.
"When evaluating the reasons for why subjects did not participate, the 3 most common reasons were patient declining to participate (30.1%), missed appointment due to hospital admission (11.1%), and surveys not provided to patient due to oncologist discomfort with discussing sexual health (11.1%)," the authors reported, reiterating the need for better education among oncologists and AAPs to address sexual health among cancer patients and young adults with cancer.
Dubin and co-authors disclosed no relevant relationships with industry.
House oversight subcommittee doesn't hold back with criticism of CMS administrator.
This article was first published on Wednesday, October 23, 2019 in MedPage Today.
By Shannon Firth, Washington Correspondent
WASHINGTON -- CMS Administrator Seema Verma faced serious castigation in her first appearance before the Democrat-led House.
The Wednesday hearing of an oversight subcommittee for the House Committee on Energy & Commerce, entitled "Sabotage: The Trump Administration's Attack on Healthcare," also saw the agency's leader respond to questions with answers that were short on details.
In her opening remarks, committee chair Diana DeGette (D-Colo.) stated that President Trump has been trying to "dismantle" the Affordable Care Act since he took office, and took Verma to task for supporting those efforts.
DeGette pointed out that under the Trump administration, and for the first time since the passage of the ACA, the number of uninsured in the U.S. has actually gone up: "About 1.9 million more people were uninsured last year compared to the year before, including nearly half a million more children," she said.
While Republicans pointed out that average premiums on the ACA exchanges are expected to drop next year by 4%, DeGette cited a study from the Kaiser Family Foundation that found health insurance premiums are 16% higher this year than they would have been if the Trump administration had not repeatedly tried to weaken the ACA.
DeGette also attacked the Trump administration's role in the Texas vs. United States lawsuit -- brought by Republican states and seeking to overturn the entire ACA -- which the Justice Department pointedly decided not to defend. If the appeals court rules the way the administration wishes, the ACA would become void and about 21 million people would lose their health insurance, DeGette said.
Verma was asked if that 21 million figure was accurate. She said "no," but did not offer her own estimate of how many people would potentially lose coverage.
Instead, she repeatedly stressed that the president has said he will have an alternative plan if the ACA is invalidated.
When DeGette pointed out that people with pre-existing conditions would also lose their health insurance if the ACA was repealed, Verma said "we will do everything we can" for people with pre-existing conditions.
She also argued that even with the ACA intact, there are people who lack protections: "If you can't afford health insurance, and you have a pre-existing condition, then you don't have protections."
DeGette continued to hammer Verma for more information on the administration's fallback plan if the ACA was repealed. "My question is, do you have a copy of the plan that will replace the ACA, yes or no?" DeGette asked bluntly.
Verma said she would not "get into any specifics." DeGette cut Verma off and yielded the floor to the next member of the committee.
Ranking member Rep. Brett Guthrie (R-Ky.) then gave Verma time to complete her answer.
Once again, Verma argued that people with pre-existing conditions do not have any real protections for their conditions if their only option is to pay a third to half of their income for health insurance.
"What we're focused on is lowering the cost of healthcare" she said, touting several of the agency's efforts to reduce administrative burden, and increase efficiencies, so that more people can afford healthcare.
Other Democrats criticized Verma for her role in those CMS efforts, such as approving and encouraging Medicaid work requirements; expanding short-term limited duration plans (sometimes called "junk plans"); and crippling the ACA enrollment by shrinking the sign-up period, cutting the ACA advertising budget, and slashing funding for health exchange navigators.
With regard to the latter, Republicans, including Michael Burgess, MD (R-Texas), argued that the ACA navigators have been much less effective than brokers.
Verma agreed. "We found the navigator programs weren't meeting their goals," she said, adding that, at times, it was costing $5,000 to $7,000 to enroll a single person in the ACA exchange.
Rep. Joe Kennedy (D-Mass.) ripped into Verma for claiming that work requirements would make people healthier, or bring them out of poverty. He noted that over 18,000 people lost health insurance in Arkansas after work requirements were enacted, as would have nearly 17,000 in New Hampshire (if the state's governor had not delayed the changes or a federal judge had not blocked them). Most of those people were working or eligible for exemptions, he said.
Kennedy cited a New England Journal of Medicine study that found that lack-of-insurance rates increased in Arkansas without an increase employment, and asked Verma to point him to a single study that proves Medicaid work requirements make people healthier.
Verma replied that "numerous" studies show "employment has a positive impact on health outcomes," but Kennedy was not buying it.
"You guys run healthcare programs in this country," he said. "I am certain you understand the difference between correlation and causation."
Verma said that she's spoken to many people living in poverty around the country, and "they want to find a pathway out of poverty."
WASHINGTON -- Pegging U.S. drug prices to those paid in other countries is not a cure-all but could help to lower costs for Americans, according to a report released Tuesday by the Bipartisan Policy Center (BPC) here.
"Today's report concludes that while reference pricing alone is not a panacea ... in the right setting, focused on the most appropriate drugs, and in combination with additional approaches, it could make a significant impact," said Anand Parekh, MD, MPH, chief medical advisor to the BPC, at a briefing to release the report.
The BPC compiled this report through information and insights derived from extensive literature review; interviews with subject matter experts, Capitol Hill staff, and drug pricing stakeholders; and information shared at a BPC roundtable held in July 2019. It delineated two types of reference pricing: external pricing, which uses international prices as a benchmark to set or negotiate the price of drugs; and internal reference pricing, which could be used in various scenarios to ensure that therapeutically equivalent drugs are priced similarly, and encourages the use of the least costly alternative therapy.
The report noted that internal reference pricing is used in 22 countries in the European Union and recommended that the Department of Health and Human Services (HHS) should consider forming an advisory group -- or task an existing office -- to compare new drugs and biologics to either existing therapeutically equivalent drugs or the standard of care as a way to help with internal reference pricing. The office or advisory group could review study data and publish an expert assessment, Parekh said. "This information would help inform private-sector price negotiations and public-sector internal reference pricing policies," he said.
"The report makes it clear that implementation of any internal reference pricing scheme [should] utilize a transparent process involving multi-sector stakeholders to identify therapeutic classes and equivalency," he added.
As for external reference pricing, which is used in 36 countries across Europe, "existing research demonstrates that external reference pricing can lead to lower medicine prices immediately, but this effect may diminish over time," Parekh said. Some studies did point to possible unintended consequences, such as higher prices in low-income countries and short-term discouragement of investment in research and development.
The report recommended that HHS consider implementing a pilot program using external reference pricing for a subset of Medicare Part B or Part D single-source brand name drugs or biologics that are relatively expensive with limited or no competition, said Parekh. One resource officials could use is the 12 guiding principles of the European Union Health Program, meant to be a reference for countries implementing an external reference pricing scheme.
Panelists at the briefing outlined some of the challenges with getting reference pricing accepted in the U.S. "The secret here is that most patients and doctors don't know how much their drugs cost" because they have a set copay for them, said David Henka, president and CEO of ActiveRADAR, a company in Gold River, California, that helps payers get doctors and patients to consider prices when deciding on treatments.
The company's program helps payers to set reimbursement rates based on the lower-cost drug of similar effectiveness in a particular category. "The member has the opportunity to have a conversation with their doctor, saying, 'Is it OK if I switch to a lower-cost drug or is there a medical reason why I need to be on the higher-cost drug?'" said Henka. "This way the transparency within the cost of the drug becomes much more apparent."
The increasing use of percentage-based coinsurance and of high-deductible health plans, in which patients have to pay full price for their prescriptions until they exhaust their deductible, may have brought the issue closer to home, aid Peter Bach, MD, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York City. He also disagreed with the idea that current methods for determining a drug's value don't take patients' quality of life into account.
"It's well-established that quality of life is a shared objective," he said. The idea of getting rid of quality-adjusted life years (QALYs) as a way to measure value -- as is suggested in the drug pricing bill championed by House Speaker Nancy Pelosi (D-Calif.) -- "is actually undercutting the patient-specific voice in measurement," he said.
But Mark Boutin, CEO of the National Health Council, a group of patient advocacy organizations here, countered that "QALY is one measurement of quality of life -- but it's not the only measurement; there are alternatives out there ... We think the Patient-Centered Outcomes Research Institute is a really good place to create alternative measurements."
Another problem with assessing a drug's value is that because patients want drugs on the market as fast as possible, "we have ended up with a portfolio of very high-cost drugs where we as clinicians don't have any data," said Bach. He gave the example of a gene therapy for spinal muscular atrophy; there are four types of SMA, and a drug was recently developed to treat SMA in children (age <2 years) based on data from patients with only one specific type -- but was FDA approved to treat all four types.
"I don't know how you counsel a family member about this therapy when there's not a single patient with any of the other three types; when you have a patient with one of the other three types in front of you," Bach said.
WASHINGTON -- What is often preventable but costs Medicare and Medicaid $37.5 billion annually? The answer: falls and subsequent injuries to beneficiaries.
"Falls are the leading cause of fatal and non-fatal injuries for older Americans, often leading to a downward spiral with serious consequences," Sen. Susan Collins (R-Maine), chair of the Senate Aging Committee, said Wednesday at a hearing on strategies for falls prevention. "In the United States, the total cost of fall-related injuries is approximately $50 billion annually, and that is expected to double to $100 billion by the year 2030. Seventy-five percent of these costs ($37.5 billion) are borne by the Medicare and Medicaid programs."
"One key cause is osteoporosis, which can be especially dangerous for people who are completely unaware that they suffer from low bone density," she continued. "While Medicare covers bone density testing, reimbursement rates have been slashed by 70% since 2006, resulting in 2.3 million fewer women being tested. As a result, it is estimated that more than 40,000 additional hip fractures occur each year, which results in nearly 10,000 additional deaths."
Collins and Sen. Ben Cardin (D-Md.) haveintroduced legislation to reverse the reimbursement cuts.
The statistics on the number and cost of falls "may not even tell the whole story because many older adults don't tell anyone when they fall," said Sen. Bob Casey (D-Pa.), the committee's ranking member. "We must remove the stigma associated with falling so that they can get the help they need to age in place – where they want to be – in their homes and communities."
Interventions, Home Modifications Needed
Casey discussed a report on the issue that the committee released Tuesday. "As our report illustrates, there are steps that can be taken to make this a reality," he continued. "I'll start with one: Physical mobility. That is key. Staying active – walking, stretching, and strength-training – all of that is proven to reduce the risk of falls among older adults."
Investing in developing and disseminating proven interventions is also important, as are home modifications. "Yet, to a senior on a fixed income, even installing a grab bar in the shower may be out of reach due to cost," said Casey. "The research community also has a role to play by ensuring that older adults are part of clinical trials, so that we know the prescription drugs they may need do not come with a dose of falling."
And last, "providers must be trained to screen patients for their fall risk and refer those in need of intervention to the appropriate service provider," he said. "A conversation that allows a provider to assess a patient should be part of every wellness visit."
Witnesses at the hearing discussed their efforts to help with fall prevention in their local communities and nationwide. Peggy Haynes, senior director of Healthy Aging at Maine Health, a healthcare system in Portland, talked about "A Matter of Balance," an evidence-based, clinically led fall prevention program developed at Boston University in the mid-1990s that has been replicated nationwide. This is "a small group program where participants learn to reduce falls and to view falling as controllable," she said.
Participants in the program's eight 2-hour classes learn exercises to increase strength and balance, and also participate in group problem-solving. Maine Health tried to offer the program in the local community, "but the expense of using clinical staff limited our dissemination," Haynes said. Maine Health was given a grant to develop a model using lay leaders, "and now classes are taught by lay coaches, who in turn are taught by master trainers."
The results in Maine have been positive, including statistically significant increases in falls efficacy, management, and control for up to a 12-month period, Haynes said. In addition, "99% plan to continue to exercise, and "A Matter of Balance" was associated with a cost savings of $938 [per person] per year. More than 6,200 Mainers have benefitted from the program," which now has master trainers in 46 states.
Need for Education
Virginia Demby, a Chester, Pennsylvania resident who advocates for older adults, has struggled with her health all her life. "I was born with some birth defects," she explained. "many things would happen to me and doctors didn't know what was wrong with me, and I would fall a lot. I'd find myself on the floor ... Before I got a wheelchair, I many times crawled across the floor to get to the bathroom because I didn't want to make a mess."
Demby eventually taught herself how to keep from falling, but many older adults haven't had fall prevention training, she said. "They end up isolated, alone, not knowing what to do." Demby said she benefited from a program called "Healthy Steps" because "there's the opportunity to learn how to be active, how to regain what you've lost." She said she now participates in line dancing, Zumba, kickboxing, weight lifting, boxing, and extreme exercise. "I used to run -- I don't do running any more because I'm very visually impaired, so now I'm walking. But I do distance walking."
Kathleen Cameron, senior director of the National Council on Aging's Center for Healthy Aging, in Arlington, Virginia, said her own mother died due to consequences of a hip fracture she sustained after a fall. "This is a health issue that crosses all genders, ethnicities, and income levels," she said. "Every hour, four older adults die from fall-related complications; this number is expected to reach seven by 2030 if we don't take significant steps now."
A Call for a Federal Effort
"We need a coordinated federal effort," said Cameron. "It could be modeled after the National Alzheimer's Model Act, and include a national awareness and action campaign." Health providers should be incentivized to use the CDC's "STEADI" (Stopping Elderly Accidents, Deaths, and Injuries) fall risk prevention program, she added.
"At the federal level, we recommend expanding payment for the 'Welcome to Medicare' and annual wellness visits to include physical therapy and occupation therapy visits ... and use the Center for Medicare & Medicaid Innovation to examine innovative payment models. We must face falls in older adults head on," Cameron said.
Sen. Mike Braun (R-Ind.) noted that "when I talk about things like wellness and prevention, the insurance industry is more interested in remediation and claims processing ... so we're on to something here." And, because diseases like diabetes, heart disease, and cancer are much more common and visible, "falls and the prevention of them will not be high on the radar screen."
Demby recommended starting fall prevention early. "It should probably be incorporated into physical education programs in schools," she said. "If fall prevention is included in the school curriculum, by the time you get to be an older adult, you know something about it. You know how to fall."
"What do I do when I know I'm going to fall? At the very instant it happens, I need to know to relax," Demby added. "Let the fall take place. When you relax there's less injury and sometimes no injury at all. I had to learn that, and there was no one to teach me."
NEW ORLEANS -- Everyone has unintentional biases, but physician practices can mitigate them with a few simple steps, experts said here.
The speakers defined unintended bias as "stereotypes or beliefs that affect our actions in a discriminatory manner." Such bias may affect our actions in a way contrary to our intentions, two speakers said at the Medical Group Management Association annual meeting.
Unintentional biases -- also known as unconscious biases -- can work against a practice's commitment to diversity in hiring and workplace inclusion, said Steve Marsh, founder of The Medicus Firm, a physician recruiting firm in Dallas. "Diversity and inclusion go hand in hand," he said. "you can do a good job of diversity hiring, but if you don't have an inclusive environment that's welcoming to all the people you brought in, it's worthless; in fact, it can backfire on you."
Achieving these goals "isn't real complicated, it's just really hard to do," he added. "You can't do a crash diet on diversity hiring; you can't do a crash diet on inclusive culture. It's a lifestyle, not an event."
Many Types of Bias
Pam Snyder, head of recruiting at Baystate Health, a healthcare system based in Springfield, Massachusetts, cited the launch of the video viewing site YouTube as an example of the perils of a non-diverse workforce. When YouTube's mobile version launched, "there was a glitch in it -- 25% of people were reporting it wasn't working," she said.
The reason? The mobile version was designed entirely by people who were right-handed and all turned their phones a certain way to see videos; left-handers turn their phones the opposite way, so the videos all appeared upside down. "Because they had that lack of diversity on their team, the product wasn't launched accurately."
A total of 188 types of unconscious bias have been identified, Snyder said. She listed four of the most common types:
Affinity bias: We tend to be more receptive to people who resemble our lives in some way. For example, Snyder was hiring a new recruiter on her team, but happened not to be there on the day one candidate came in for an interview. But during a follow-up phone call about the candidate, "I had at least three different staff people say, 'You're going to love her; she reminds me of your daughter.' That was their affinity bias."
Confirmation bias: We look for information that supports our beliefs and ignoring details to the contrary. Snyder, who is from Tennessee, explained that "when you hear someone with an accent like mine ... you think they're not well-educated. Confirmation bias is when you look for things when you're talking to someone that confirms that."
Halo effect: There's something good about someone and because of the one good thing, we think everything about them is good. "In Tennessee, when we got a CV [curriculum vitae] and it was from a Harvard grad, we're like, 'We've hit the jackpot,'" she said. "This halo effect was real; there were things we'd ignore about that candidate because of what was on their CV."
Perception bias: This one is "really scary, worse than confirmation bias," said Snyder. "You know it -- you've met one person that had these physical and emotional attributes and you've formed your opinion and you can't get away from that. That's really the scariest when it comes to recruitment."
Steps to Overcome Bias
To overcome unintentional bias, "the first thing we have to do is accept the fact that we have it," said Snyder. "We can't control the experiences we have had." She suggested taking an "implicit association" test such as this one offered by Harvard. "You need to take an honest look at your unconscious."
To mitigate bias and foster a diverse workplace, organizations are moving toward competency and evidence-based recruitment, she continued. Part of the competency-based evaluation for interviewees involves asking behavioral event interviewing (BEI) questions involving something the person experienced in the past. Such questions often begin with "Tell me about a time when..."
For example, one practice wanted to know whether its candidates for a physician slot would be able to handle the workload, which involved seeing as many as 25 patients per day with only one medical assistant and a shared RN. So they might ask candidates the following about their previous job experience: "Tell me how many patients you saw in a day and what support you had." If the candidate answers, "I saw 10 patients a day, and had two medical assistants and my own RN," that might mean that the candidate isn't a good match for the position, she said.
A question to ask when you want to find out about the candidate's teamwork abilities is, "Describe a time when you were part of a team that worked well together. What role did you play? How did you show respect for others on the team?" said Snyder. Candidates' egos can really be revealed with this answer; if they answer the question by just talking about themselves, "it's a big red flag for us."
When developing questions for a competency-based evaluation, it's important to get buy-in from the staffers working in the department being recruited for, and to ask all the candidates the same questions, she said. Having a diverse panel of interviewers is also critical. "If you're looking at an interview panel of all white males, you failed." Also, panelists should work in a variety of positions at the company -- "If you're hiring a surgeon, you need someone from the surgery department that's a non-provider ... When you have those different inputs, you get a stronger decision."
Benefits of Diversity
In addition to unintentional biases, practice managers need to be on the lookout for intentional ones as well, according to Marsh. "Over the last 2 or 3 years, I've seen one of the biggest intentional biases ever creep in: politics," said Marsh. "Five times in the last 2 years -- not in group settings, but in individual meetings -- I've heard, 'We can't recruit a Republican' or 'We can't recruit a Democrat.' I've heard it on both sides of the aisle. People have some very strong polarizing biases in the environment we're in right now, but it has nothing to do with competency. It has nothing to do whether they're good for this role."
Hiring a diverse workforce results in more creativity, according to Marsh. "You have all these ideas coming in that you never would have had if everybody looked and acted the same," he said. "If we're able to create an environment where everybody has a voice, you're going to have meetings -- and be thankful for them -- where somebody says, 'I don't think that's a good idea.' If you have an inclusive environment and welcome additional ideas, many times you'll avoid pretty bad circumstances."
Once a diverse workforce is on board, the next step is to work on inclusion, defined as "a feeling of belonging, a feeling of being appreciated for unique characteristics, and the extent to which employees feel valued, respected, accepted, and encouraged to fully participate," said Marsh. And you have to have a meaningful process for addressing bias-related concerns. "You can do everything right, with all the good intentions in the world, but if you're scared to address the issues, it all goes for naught because everybody's watching."
Intra-articular injections of corticosteroids for relief of the pain of hip or knee osteoarthritis (OA) may have adverse long-term consequences, researchers suggested.
These injections are commonly performed and have been "conditionally" recommended by the American College of Rheumatology and "should be considered," according to the Osteoarthritis Research Society International. The American Academy of Orthopedic Surgeons, however, has advised clinicians to be on the lookout for emerging evidence for or against the use of intra-articular injections in the knee, explained Ali Guermazi, MD, PhD, of Boston University School of Medicine, and colleagues.
However, a review of the outcomes following 459 injection procedures performed during 2018 in a single center now has identified four potential adverse events that should raise concerns, particularly for certain patients:
Accelerated OA progression, reported in 6% of patients
Subchondral insufficiency fractures, seen in 0.9%
Complications of osteonecrosis, in 0.7%
Rapid joint destruction including bone loss, also in 0.7% of patients
A Cochrane meta-analysis evaluated 27 trials that included more than 1,767 patients found moderate improvements in pain and slight benefits for physical function following intra-articular corticosteroid injections for knee OA. However, the review noted that the quality of evidence was low, concluding that the results were inconclusive.
"Whether there are clinically important benefits of intra-articular corticosteroids after 1 to 6 weeks remains unclear in view of the overall quality of the evidence, considerable heterogeneity between trials, and evidence of small-study effects," the Cochrane reviewers wrote.
In an editorial accompanying the Boston University report, Richard Kijowski, MD, of the University of Wisconsin in Madison, wrote, "The use of intra-articular corticosteroid injection to treat OA remains commonplace in clinical practice despite the lack of strong evidence supporting its efficacy."
In vitro and animal research has revealed that corticosteroids actually can have negative effects on cartilage. "The action by which corticosteroids are chondrotoxic is complex, but it seems to affect cartilage proteins (especially aggrecan, type II collagen, and proteoglycan) by mediating protein production and breakdown," Guermazi and colleagues explained.
Moreover, the local anesthetics often combined with the steroids also have been linked with chondrolysis.
And a recent retrospective study of 70 patients with hip OA found that 44% of patients who were given injections of triamcinolone with ropivacaine had radiographic progression and 17% experienced collapse of the articular surface.
"Thus, there is a growing body of evidence to suggest that intra-articular corticosteroid injection can accelerate the progression of joint degeneration," Kijowski observed.
The Events
The injection protocol used at Boston University involved 40 mg triamcinolone, 2 mL of 1% lidocaine, and 2 mL of 0.25% bupivacaine.
Accelerated OA progression, characterized by rapid loss of radiographic joint space, was first observed in trials of nerve growth inhibitors, wherein some patients required joint replacement earlier than had been expected. Some experts have suggested that a loss of joint space exceeding 2 mm within a year can be considered accelerated progression, which can be accompanied by effusions, synovitis, and local soft tissue changes.
This accelerated OA progression was seen in 26 patients, following hip injections in 21 patients and knee injections in five.
Subchondral insufficiency fractures were the second type of adverse outcome observed, and were seen in four patients undergoing intra-articular hip injections. This event was previously thought to occur in elderly patients with osteopenia, but has now been reported in younger, active patients who present with acute pain but no apparent trauma.
The affected area often is weight-bearing and may involve loss of cartilage and meniscal tearing. Radiographic findings can be normal or subtle, while on magnetic resonance imaging (MRI) subchondral hypointensity may be detected. If the condition is identified early, before articular collapse has occurred, healing can occur, but once the articular surface has collapsed, the joint must be replaced.
Early identification of subchondral insufficiency fractures also is crucial before intra-articular injections, because the steroid may interfere with resolution of the fracture. Moreover, if an injection is performed and results in pain alleviation, the patient may increase weight-bearing and worsen the insufficiency fracture, hastening collapse.
The third type of event the researchers identified involved complications of osteonecrosis, which typically present with insidious onset of pain or can be asymptomatic. MRI is required for the diagnosis, and can help predict collapse by the extent of osteonecrosis and bone marrow edema. Once collapse has occurred, the only option is joint replacement.
The fourth adverse outcome, rapid joint destruction including bone loss (also referred to as rapidly progressive OA type 2), occurred in two patients with hip injections and one following a knee injection. Some previous authors likened this event to accelerated osteonecrosis, and others have hypothesized that the joint destruction results from undiagnosed subchondral insufficiency fractures.
The Advice
There are currently no recommendations regarding imaging before performing an intra-articular corticosteroid injection, and in some cases, findings may be subtle. "However, given the relative ease of performance and the low cost of radiography, there should be a low threshold to obtain radiographs before performing an intra-articular corticosteroid injection, as the intervention may affect the disease course (i.e., it may result in accelerated progression)," Guermazi and colleagues wrote.
Of particular concern are patients who have no apparent OA or very mild changes on radiographs who have been referred for injections because of pain. In these cases, the indication for injection should be "closely scrutinized," as destructive or rapidly progressive joint space loss tends to develop in patients with severe pain but minimal structural change on radiographs.
"Clinicians should consider obtaining a repeat radiograph before each subsequent intra-articular injection to evaluate for progressive narrowing of the joint space and any interval changes in the articular surface that can indicate subchondral insufficiency fracture or type 1 or 2 rapidly progressive OA," the authors advised.
"We believe that certain patient characteristics, including but not limited to acute change in pain not explained by using radiography and no or only mild OA at radiography, should lead to careful reconsideration of a planned intra-articular corticosteroid injection," the authors concluded, adding that MRI may be helpful in these circumstances.
"Patients might be more than willing to take the small risk of an adverse joint event requiring eventual joint replacement for the possibility of at least some degree of pain relief after intra-articular corticosteroid injection," wrote Kijowski.
"However, patients have the right to make this decision for themselves," he stated.
Guermazi reported being a shareholder of Boston Imaging Core Lab, and having financial relationships with TissueGene, Merck Serono, Pfizer, AstraZeneca, Galapagos, and Roche.
Kijowski reported research funding support from GE Healthcare.
NEW ORLEANS -- Medical practices that want to make their offices welcoming and inclusive for lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals can signal their intention with subtle indicators, Jesse Ehrenfeld, MD, MPH, said here Monday.
"Take inventory," Ehrenfeld, who is director of the Advancing a Healthier Wisconsin Endowment at the Medical College of Wisconsin, in Milwaukee, said at the annual meeting of the Medical Group Management Association. "Have something rainbow-flavored somewhere," such as a "safe space" sticker or a flag on the desk, or subscribe to LGBTQ-themed magazines and leave them in the waiting room. He noted that in his prior job at Vanderbilt University, the staff put up signs on all of the single-stall bathrooms indicating that they were gender-neutral. "Straight patients won't notice, but it will mean the world [to others]."
Ehrenfeld, who is the first openly gay chair of the American Medical Association's board of trustees, said he himself always looks at the non-discrimination language that healthcare facilities are required to post in their waiting rooms, to see if information about gender identity has been added. "It's just one of those subtle things I kind of notice." At his current facility, the pediatric unit used to have paperwork with spaces for information about "Mom" and "Dad," and they have changed it to "Parent 1" and "Parent 2," which works for all kinds of families, he added.
Such reminders can be welcome to a significant portion of your patient population, said Ehrenfeld. "Every day, no matter where you work or what you do, you'll be taking care of LGBTQ folks." He cited a survey showing that:
4.1% of U.S. adults -- 10 million people -- identify as LGBT
8.2% report same-sex behavior in their lifetimes
11% report having had same-sex attraction at some point
Transgender numbers are a little harder to pin down, but one survey estimated transgender individuals as about 0.6% of the U.S. population. Furthermore, almost 2% of high school students in the U.S. identify as transgender, and 27% of them feel unsafe at school; 35% say they are bullied because of being transgender, and 35% have attempted suicide. In addition, almost 40% of homeless adolescents are LGBT, said Ehrenfeld.
Access to care is also more difficult for this population, with LGBT patients twice as likely to be uninsured as other patients. "And when people do have coverage and come see us, they often don't get the best care," he added, with 56% of LGB and 70% of transgender patients reporting that they encounter bias or discrimination when accessing care. "If you come to the doctor's office and are told, 'I don't take care of people like you,' what do you do? Well, you don't go back."
Even in urban areas where more acceptance might be expected, "it's really hard to find knowledgeable, friendly providers," said Ehrenfeld. He spoke with one endocrinologist in the Washington, D.C., area who said he had a transgender patient who had previously gone to six other endocrinologists -- none of whom had been willing to take him as a patient.
He reviewed questions that should and shouldn't be asked of LGBTQ patients. Those that should be asked include, "Is there a name you use that is different from what is on your chart?" and "Is there a gender pronoun that you use that is different from what is on your chart?" Inclusive policies can also be incorporated into the patient intake workflow -- for instance, many facilities have stopped putting gender on patient armbands because it's not clinically relevant, but have added patients' preferred names.
Questions not to ask include anything that is clinically irrelevant and those that are just to satisfy your personal curiosity. He gave an example of a senior leader at Vanderbilt who was openly gay; one day, his secretary said to him, "I just don't quite understand. You and your husband -- who's doing what?" He responded, "I think you just asked, am I the insertive or receptive partner. Is that what you really wanted to ask?"
"She said, 'Oh my God -- I'm so sorry,'" Ehrenfeld said. "People unfortunately are asked these inappropriate things lots of times.... Just be thoughtful about the questions you're asking."
On the other hand, LGBTQ patients do want to be asked clinically relevant questions, he said. One study by researchers at Johns Hopkins University found that while patients don't mind being asked about their sexual orientation -- whether it's by a registration clerk, an RN, or a physician -- "on the staff side, we are afraid," Ehrenfeld said. "The vast majority of patients want to be asked, and the vast majority of healthcare workers think that we shouldn't ask because I'm going to, like, turn someone off."
One way to improve the way your practice treats LGBTQ patients is to use the Healthcare Equality Index, a free tool developed by the Human Rights Campaign (HRC), an organization that promotes LGBTQ rights, Ehrenfeld said. The index allows practices and health systems to rate themselves on their policies in areas such as patient non-discrimination, equal visitation, and employment non-discrimination. Of the 680 facilities who participated in the index in 2019, 408 earned a score of 100 points, giving them a designation of "Leader in Healthcare LGBTQ Equality," according to the HRC website -- a designation that facilities can post on their website to further indicate their inclusive policies.
Another way to make your practice more inclusive is through a Trans Buddy Program, such as the one Vanderbilt implemented in 2015 for its transgender patients. The program involves using community-driven trained volunteers to accompany patients to appointments, he explained.
"It is so hard to be a male-presenting trans woman in ob/gyn clinic -- to show up to women's health to get your Pap smear and you've got a beard -- it's just awful." Ehrenfeld said the program has been very successful, is free, and anyone can be referred to it.
WASHINGTON -- If the drug price bill sponsored by House Speaker Nancy Pelosi (D-Calif.) passes Congress, it will mean "lights out" for small start-up biopharmaceutical firms that depend on venture capital, Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), said Thursday.
"We don't want to overstate the case... but for the [drug development] ecosystem as a whole, this would be nuclear winter in places that depend on early-stage financing for biotech innovation," Ubl said during a press briefing at PhRMA's headquarters here.
Allow the Secretary of Health and Human Services (HHS) to negotiate prices with drug manufacturers for 250 drugs annually for which there's no competition. The secretary will negotiate a maximum fair price that will be applied to the Medicare program, and will also be available to private insurers. The negotiated price will have an upper limit of 120% of the volume-weighted average price of six countries (Australia, Canada, France, Germany, Japan, and the U.K.)
Establish a mandatory rebate for drug manufacturers of all drugs covered under Medicare Part B and Part D that increase their prices faster than inflation
Cap out-of-pocket costs at $2,000 for Medicare beneficiaries enrolled in the Part D drug coverage program
"We still have lot of work to do in terms of ensuring we get to a balanced place at the end of this debate," Ubl said. "If you look at things like rebate reform, we think there is bipartisan interest in those policies. I think there is significant bipartisan support [for some provisions] but we're not there yet ... I don't think members are interested in our endorsements and there is going to be pain associated with those provisions, but I'd hope it would be the beginning of policymakers and others looking at industry in a different way."
Pelosi's bill "is a much more far-reaching proposal that could have a devastating impact on the industry and the patients we serve," he continued. For example, the bill's price-setting provision suggests that prices could be set for as few as 25 medications, "but the way it's drafted, it could allow for 250 medications per year... It wouldn't take long for the vast majority of medicines to become subject to this provision. It doesn't just apply to government programs but to the commercial market as well." In addition, "it's more coercion than negotiation because if the company does not accept the government price, there's a 95% tax on the product in question."
"We see the Pelosi package as innovation killer, as a job killer, and ultimately a hope killer for American patients waiting for better cures," said Ubl. "It's an innovation killer because it takes a $1 trillion hit on pharmaceutical innovators over 10 years."
Ubl also asserted the bill would cost 1 million jobs and quash industry research on difficult-to-treat diseases such as Alzheimer's and ALS.
Lori Reilly, JD, chief operating officer of PhRMA, discussed the association's concerns with the Part D provisions in the drug price bill passed by the Senate Finance Committee, which is chaired by Sen. Chuck Grassley (R-Iowa). She cited a new report from Avalere, a healthcare consulting firm, which found that the bill would increase drugmakers' liability for price discounts in the Part D program by an average of 69% -- but the percentage would be much higher for certain classes of drugs. For example, the discount liability for makers of antiretrovirals to treat HIV would increase more than eight-fold, or $1.82 billion, relative to the discounts paid today, while for certain respiratory drugs, the increase would be about 5.5-fold, or $240 million.
"Part of the concern is that this is sending the message that if you make these medications now or in the future, you face a very very high tax or penalty that you're going to have to face for potentially an unlimited period of time," she said, adding that some provisions in the Pelosi bill increase manufacturers' liability even more than that.
"We have been supportive of establishing an out-of-pocket cap in Part D; that's not the issue," Reilly added. "The issue is that we believe [the manufacturer liability] is too high."
Ubl had his own criticism of the Finance Committee bill, noting that it "siphons off $150 billion from industry R&D." However, when asked about it by MedPage Today, Ubl acknowledged that the bill doesn't specifically take money from drug companies' R&D budgets. Rather, "if it comes out of industry, we think a large share of it would come from R&D expenditures, because in general, there are fixed costs and there are discretionary costs, and R&D expenditures are the most discretionary expenditures a company can make," he said.
Not everyone agrees with the idea that the Pelosi bill would hurt small-cap startup companies. "Most of the money to fund preclinical trials (phase 1 and 2) [is] from the National Institutes of Health; this will not be affected by the legislation," Gerard Anderson, PhD, professor of health policy and management at Johns Hopkins University in Baltimore, said in an email. And the bill's price negotiation provisions "will only affect the best-selling drugs, so if it is a drug in a small market it will not be affected ... I can see that [these companies] will be concerned but it is unlikely to affect them."
Rep. Lloyd Doggett (D-Texas), chairman of the House Ways & Means Health Subcommittee, took issue with PhRMA's criticism of the Pelosi bill. "To describe this narrow bill as producing 'nuclear winter' makes one wonder what cataclysmic term would be applied to genuinely comprehensive negotiation legislation," Doggett said in a statement. "This grim term better describes the fallout from monopoly prices which patients are suffering."
WASHINGTON -- Attending to patients' social determinants of health has to involve more than just screening for issues such as food insecurity and transportation problems, several speakers said here.
"A lot of the conversation about social determinants of health (SDOH) ... [has been] about screening and how do you screen within your organization," said Megan Reyna, of Advocate Aurora Health, in Downers Grove, Illinois. "Doing that process, we learned that there is a whole other conversation we need to talk about -- with engaging our social service agencies, engaging the community, and engaging our patients. And the next step is also looking at local policy change and how we implement this on a national level as well."
At the Physician Organization of Michigan (POM) Accountable Care Organization, the management formed a committee to develop a creative way to finance its work in the SDOH area, said Terrisca Des Jardins, administrative director of the POM Accountable Care Organization (ACO), at the annual meeting of the National Association of ACOs (NAACOS) last week.
"We really need to think about what creates health," said Des Jardins. She noted that 20% of health is attributed to clinical care, "but the balance is health behaviors, social and economic factors, and physical environment. As we start thinking about the future, we need to also start thinking about these other dimensions that may not have been top of mind [before]."
The committee's goal "is to maximize the impact of prospective community benefit investment through an inter-hospital and cross-geography coordination of community benefit donations that target specific population needs in an aligned, impactful, and measurable way. This has never been done before that we know of," said Des Jardins. "I don't know that it's going to work, but we're giving it our best."
In addition to pursuing hard dollars, they're also looking at policies in their own institution that will have impact downstream -- "for example, a policy commitment to hire individuals from the hospital community as a means to improve that community. Another example could be providing a living wage to all workers ... This is going to be a huge lift, obviously."
Des Jardins said her own awareness of SDOH began in 1998 when, while working in New Mexico to find out about the concerns of Medicaid patients there, "the group didn't want to talk about the Medicaid benefit package; they wanted to talk about running water and electricity. That was a real eye-opener for me."
Later, when she was working in a community program related to health information technology, "we found that as we talked to the 'super-utilizers' of the ED [emergency department], when we really had an examination of what was causing people -- particularly Medicare beneficiaries -- to visit the ED, we found they were lonely, or socially isolated."
She carried on this concern when she came to her current job, and implemented a pilot SDOH screening questionnaire at several ACO sites. However, as an ACO, "we don't dictate how people handle specific interventions, so each organization that took on implementing a screening used their own tool. Some included questions on social isolation and loneliness, and some did not." Regardless, that issue of social isolation and loneliness still came up as the single largest social determinant flagged, including among new moms, Des Jardins said.
The next step is to figure out a solution to the problem, she added. "We don't have a solution now, but we think we've identified a creative financing mechanism, and we've identified what could be a significant driver of utilization and success into the future."
Part of the problem in determining patients' SDOH needs is that data collection is very fragmented, said Caitlin Dunn, director of population and digital health at Inception Health, a project of Froedtert Health and the Medical College of Wisconsin in Milwaukee. Her organization, for example, found that it was collecting SDOH data in 997 places in the medical record. And because it's in so many places, "I couldn't tell the system executives the needs of our population -- how many have food insecurity, how many had experienced domestic violence, how many are homeless."
As a result, "The senior leadership team is unclear on our health system's strategy and its role in solving non-medical problems," she said. "Every year, when we go through our strategic planning process, I look for what we are putting of SDOH into our strategic plan. It never comes out like I think it should ... It always ends up being screening."
However, the organization is beginning to make some progress, Dunn added. "Over the past year, we did implement a standard screening tool. It's not perfect, but at least I can tell my executives that over the month of July, we found 17 new people with food insecurity. That's a real thing that they can connect with, and they can imagine interventions they can do because of it."
Dunn's organization is working with other community groups in Milwaukee under the auspices of the "Impact 211" program, an effort by individual communities nationwide to build a 24/7 resource for people to turn to when they have social needs such as housing, transportation, medical care, and food. "We're planning a digital tool that we could make available to our community," she said. "We're at the start of a demonstration project; three of the major health systems and one federally qualified health center have agreed to be part of it," in addition to a variety of community organizations.
"We have a goal of screening 100,000 people in the community through this tool; just imagine the power of that data if you could do it," said Dunn. However, she added, some CEOs of community social service organizations "are concerned that once we turn this tool on, they're going to get this influx of referrals and they're not going to be able to help those people. I'm going to be interested to see the community's reaction if that starts happening."
Also associated with short-term mortality in Medicare patients with pneumonia, heart problems.
This article was first published on Wednesday, September 25, in MedPage Today.
By Ashley Lyles, Staff Writer, MedPage Today.
Frailty in elderly Medicare recipients hospitalized for acute MI, pneumonia, or heart failure was linked with a greater risk of readmissions and death, a nationwide cohort study found.
In patients hospitalized for acute MI, for example, those with high-risk frailty scores had a threefold greater risk of readmission at 30 days compared with low-risk individuals (adjusted odds ratio [aOR] 3.0, 95% CI 2.9-3.1), reported Robert Yeh, MD, of Beth Israel Deaconess Medical Center in Boston, and colleagues,
And these patients were at greater risk of 30-day mortality, measured either from the time of admission (aOR 3.6, 95% CI 3.4-3.8) or from discharge (aOR 4.0, 95% CI 3.7-4.3), as described in JAMA Cardiology.
The authors reported similar 30-day trends for patients hospitalized with pneumonia and heart failure, respectively:
Readmission: aOR 2.8 (95% CI 2.7-2.9) and aOR 2.9 (95% CI 2.8-3.0)
Postadmission mortality: aOR 2.5 (95% CI 2.3-2.6) and aOR 3.5 (95% CI 3.4-3.7)
Post-discharge mortality: aOR 3.0 (95% CI 2.9-3.2) and aOR 3.5 (95% CI 3.3-3.6)
"Unless frailty is adequately captured in risk-adjustment metrics, it is possible that hospitals that care for a higher proportion of frail patients are disproportionately financially penalized for worse outcomes owing to unrecognized comorbidities among the patients they care for, rather than quality of care delivered," Yeh's team wrote.
For their study, high-risk frailty was defined as a Hospital Frailty Risk Score (HFRS) greater than 15, while an HFRS below 5 was low-risk frailty.
Prior research has looked at frailty and its impact on cardiovascular procedures, such as transcatheter aortic valve replacement and heart transplantation, among others, Sean Pinney, MD, of the Mount Sinai Health System in New York City, told MedPage Today. The literature has expanded experts' understanding of what frailty is and the negative impact that frailty has on cardiovascular outcomes, he added.
"As practitioners, we are becoming more aware of the need to identify patients who are frail, to come up with screening systems that are easy to deploy, that are highly accurate, and also provide some actionable information in order to try to allow patients who are frail to become more robust, so that they can prevent rehospitalization in the near future," said Pinney, who was not involved in the study.
In all, Yeh's group evaluated 785,127 Medicare fee-for-service recipients at acute care hospitals using the Centers for Medicare & Medicaid Services (CMS) Medicare Provider Analysis and Review files -- 166,200 who were hospitalized for acute MI, 270,308 for pneumonia, and 348,619 for heart failure. At the time of hospitalization, mean patient age was 79.2. The cohort was 51.3% women and 83.6% white.
Mean HFRS was 10.8 for patients with heart failure, 8.2 for patients with pneumonia, and 7.3 for patients with acute MI. Multivariable adjustments accounted for sex, race, age, and comorbidities.
Study limitations included that the severity of patients' conditions and change post-procedure may not be fully captured by administrative codes, the authors noted. Also, the HFRS was established to identify clusters of healthcare use and may not be beneficial for identifying phenotypic frailty, plus it is unknown to what extent frailty contributes to elevated risks of healthcare use compared to comorbidities alone.
"Further research is needed to understand whether the addition of frailty as measured by the HFRS to current CMS risk-adjustment models affects which hospitals are financially rewarded or penalized under current value-based programs," the researchers concluded.
The study was funded by the National Heart, Lung, and Blood Institute.
Yeh disclosed relevant relationships with Boston Scientific, Abbott Laboratories, Teleflex, Medtronic, and Abiomed.
Pinney disclosed relevant relationships with Abbott, CareDX, Medtronic, and Procyrion.