Top 10 Health Tech Hazards for 2019, Not All What You Would Think

The potential for hackers to exploit remote access systems to infiltrate a healthcare organization’s networked devices and systems is the number one health technology hazard that hospitals should focus on in 2019, according to the ECRI Institute.

Such attacks can disrupt healthcare operations, hinder the delivery of care, and put patients at risk, the nonprofit research organization warns in its just-released 2019 Top 10 Health Technology Hazards.

Produced each year by ECRI’s Health Devices Group, the list identifies potential sources of danger that ECRI believes warrant the greatest attention for the coming year. The list is accompanied by practical strategies hospitals and healthcare providers can take to reduce the risks.

Cybersecurity is clearly a growing concern. In the past 18 months, the ECRI published 50 cybersecurity-related alerts and problem reports, a major increase over the prior period, the group notes.

“The consequences of an attack can be widespread and severe, making this a priority concern for all healthcare organizations. In critical situations, this could cause harm or death,” David Jamison, executive director of the Health Devices Group at the ECRI, said in a news release.

Organizations need to identify, protect, and monitor all remote access points and adhere to recommended cybersecurity practices, such as instituting a strong password policy, maintaining and patching systems, and logging system access, the group says.

Taking the number 2 spot on the latest top tech hazards list are mattresses and mattress covers that remain contaminated with blood and other bodily fluids after cleaning, posing an infection risk. “Healthcare facilities must take care to use appropriate products and procedures for cleaning and disinfecting mattress covers, and they should regularly inspect mattresses and covers for signs of damage or contamination,” the group advises.

“One key challenge, however, is that not all mattress cover suppliers recommend products and procedures that will successfully remove the likely surface contaminants without compromising the cover’s integrity (ie, creating weak spots that could allow leaks). This situation needs to be remedied,” they conclude.

Number 3 on this year’s list are surgical sponges unintentionally left inside the patient after the surgical site is closed, which can lead to infection and other serious complications, including the need for another surgery.

Manual counts, in which the surgical team verifies that all sponges are accounted for before concluding the procedure, are standard practice, but errors in counting can occur, the group notes. “Technologies that supplement the manual counting process are available and have been found to be effective when used correctly. ECRI Institute contends that broader adoption of these technologies could further reduce the risk that a surgical sponge will be unintentionally retained during a procedure,” they say.

Number 4 on the list is improperly set alarms on ventilators, which put patients at risk for hypoxic brain injury and death. “Properly set alarms can prevent such consequences. Yet ECRI Institute continues to investigate deaths resulting from breathing circuit disconnections during which no alarm activated. In two cases from early 2018, alarms to detect inadequate ventilation, such as the minute-volume and low-pressure alarms, were not set appropriately,” the group notes. “Healthcare facilities need policies on setting user-adjustable ventilator alarms and protocols for verifying that the policies are being followed and that component connections are secure.”

Number 5 on the list is mishandling flexible endoscopes after disinfection, which can cause infections in patients. Cleaning and disinfecting flexible endoscopes between uses can be challenging, and failure to adhere to a strict reprocessing protocol can lead to infections. “Less well known is that improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections,” the group notes.

When endoscopes are not completely dried after disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments. “To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process,” the group states.

The “clean” status of endoscopes can also be compromised if the instruments are handled with unclean gloves, which the ECRI has observed. “Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; thus gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine,” they caution.

“Recontamination can also occur when transporting and storing endoscopes. Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces,” they add.

The Final Five

Rounding out the top 10 technology hazards ECRI says warrant the greatest attention in the coming year are the following:

6. Confusing dose rate with flow rate, which can lead to infusion pump medication errors.

7. Improper customization of physiologic monitor alarm settings, which may result in missed alarms.

8. Injury risk from overhead patient lift systems.

9. Cleaning fluid seeping into electrical components, which can lead to equipment damage and fires.

10. Flawed battery charging systems and practices that can affect device operation.

More information about the ECRI ranking is available on the group’s website.

https://www.medscape.com/viewarticle/902856#vp_1

Dialysis-Facility Joint-Venture Ownership — Hidden Conflicts of Interest

Despite potential benefits of joint ventures between dialysis companies and nephrologists, these arrangements raise legal and ethical concerns. And because of a lack of transparency, it is impossible to study whether these concerns are borne out in practice.

From the Perelman School of Medicine at the University of Pennsylvania (J.S.B., A.G., M.S.M.), and the Hospital of the University of Pennsylvania (J.S.B.) — both in Philadelphia.

https://www.nejm.org/doi/full/10.1056/NEJMp1805097

Fitbit data helps police arrest another murder suspect

Fitbit may have helped police solve the murder of one of its users, after investigators used heart rate data to determine the identity of the alleged killer. On September 8th, Anthony Aiello visited his 67-year-old stepdaughter Karen Navarra in San Jose. He claims he brought homemade pizza and biscotti for her, and she walked him to the door and gave him a couple of roses as a thank you. But data from Navarra’s Fitbit Alta showed a different story, according to investigators.

The data indicated that Navarra’s heart rate “spiked significantly,” then rapidly slowed and stopped — all during the 15 minutes or so that Aiello, 90, was in her home, the New York Times reports. One of Navarra’s coworkers found her body five days after Aiello’s visit.

Investigators used surveillance footage to determine that Aiello’s car was parked in Navarra’s driveway during the unusual heart rate activity. They found that he left around five minutes after her heart stopped. Police arrested Aiello September 25th and he’s been charged with murder.

After obtaining a search warrant, investigators procured the Fitbit data with the company’s help. Fitbit’s privacy policy states that it “may preserve or disclose information about you to comply with a law, regulation, legal process, or governmental request.”

It’s not the first time Fitbit data has helped police find an alleged killer. Data from a Connecticut woman’s fitness tracker led police to charge her husband with her 2015 murder. He was arrested last year and is awaiting trial. Earlier this year, investigators used Fitbit data in the case of Iowa student Mollie Tibbetts. The 20-year-old student was missing for around a month before her body was found in August, and a 24-year-old man has been charged with her murder.

https://www.engadget.com/2018/10/04/fitbit-data-heart-rate-murder-arrest/

Mental health parity remains a challenge 10 years after landmark law

This week marks 10 years since the landmark bill, Mental Health Parity and Addiction Equity Act, was signed into law, signifying one of the single biggest achievements over the past decade in the fight to expand access to mental health and substance use disorder treatment services.

While some viewed the legislation at the time as the apex in a decades-long battle for equity in coverage for behavioral healthcare, advocates contend access to care for millions remains elusive.

“Unfortunately, we’re still not taking serious mental illness as seriously as we need to,” said John Snook, executive director for the Treatment Advocacy Center. “I think the realities around the costs that we incur are still not there when we’re talking about covering those costs on the front end.”

Chuck Ingoglia, senior vice president of policy and practice improvement for the National Council for Behavioral Health, said while the law is simple in its conceptualization that mental health and addiction treatment should be treated the same way as medical and surgical benefit, attempts to implement it has faced significant challenges.

At the heart of the problem has been a lack of consistency in the oversight and enforcement on the part of federal and state regulators to get insurers to comply with existing parity laws. Though enforcement largely falls on states, many of their laws are not robust, and varying their standards leave wide disparities.

Advocates feel much progress has been made in addressing and reducing some of the more obvious disparities in treatment. Some of those barriers to treatment have included placing stricter limits on the number of inpatient and outpatient mental health visits, separate prior authorization requirements than for medical care services, and separate deductibles and copays.

Angela Kimball, national director of advocacy and public policy for the National Alliance on Mental Illness, said many of these types of traditional barriers on mental health and substance use disorder treatment have been reduced or eliminated because of the Federal Parity Law. “What remained were much more subtle discriminatory practices,” Kimball said.

Many of the barriers that still exist come from what are known as insurer non-quantitative treatment limitations, which Kimball said have kept patients from realizing the true intent of the Federal Parity Law.

Such limits include differences in how health plans enact utilization management and how they define medical necessity, separate deductibles and co-pays for mental and medical healthcare, limited behavioral healthcare services offered within their provider networks, and lower reimbursement for behavioral healthcare providers, to name a few.

The impact of such limits on access to mental healthcare has been significant. Behavioral health patients are four times more likely to go out of network to get care, which raises the cost for such services, according to a 2017 report by actuarial firm Milliman. The report found out-of-network providers provided 32% of behavioral outpatient care in 2015 compared to 6% of medical/surgical care in the same setting.

In terms of reimbursement, the Milliman report found behavioral healthcare providers were paid on average more than 20% less than primary care services and 17% less than the average paid for specialist services.

Ingoglia said he has just begun to think about possible ways to improve the federal statute in order to address the gaps in access to mental healthcare and substance use disorder treatment caused by non-quantitative treatment limits.

But the focus over the years has been on improving state oversight and enforcement of parity laws, which many see as facilitators of mental healthcare and substance use disorder treatment coverage parity protections. Evidence has found states lack consistent definitions on what constitutes mental health and substance use disorders, how they are covered by insurance, and how much effort should be given toward enforcing compliance.

“We see disparities in terms of states in their willingness to actually try and enforce that intent,” Kimball said. Overall all but a handful of states have statutes in place that provide adequate protections for mental health and substance use disorder.

Such was the finding of a new report released this week by the organization ParityTrack, a group started by former U.S. Congressman and recognized mental health advocate Patrick Kennedy. The report tracked and examined parity laws in all 50 states and gave low marks for 43 while only giving high marks to one, Illinois.

In May Illinois passed legislation that has been touted as one of the toughest parity enforcement laws in the country, which expanded the type of health plans covered under parity requirements to include local, county, and school district health plans. All of those types of plans can opt out of compliance to the Federal Parity Law.

Paul Gionfriddo, president and CEO of Mental Health America, said the federal government had a role to play in helping to create a more uniformed expectation for parity compliance for all states.

“Even though the states really have the roles to regulate insurance historically, the federal government can establish certain boundaries,” Gionfriddo said. “The federal government’s guidance to the state is critically important in making sure that somebody who lives in Florida gets the same kind of care as somebody who lives in Illinois who gets the same kind of care as somebody who lives in Connecticut.”

Kimball said it would make sense if the federal government sent a consistent message on expectations for parity. But she felt the Trump administration’s final rule in August to expand access to short-term, limited duration insurance coverage sent the opposite message since those plans under the rule do not have to comply with the Federal Parity Law.

“Despite the gains that we’ve seen over the past 10 years, we’re also seeing a lot of attempts to take us back in time to when people were blatantly discriminated against,” Kimball said.

Pamela Greenberg, president and CEO of the Association for Behavioral Health and Wellness, which represents “payers that manage behavioral health insurance benefits,” agreed a more uniformed standard by which states assessed parity compliance would be helpful. She envisioned a standard by which states asked for the same type of documentation from insurers to prove their compliance.

Kate Berry, senior vice president of clinical affairs for the America’s Health Insurance Plans, said greater insurance compliance was just one part of achieving mental health parity and contended it also involved engagement with clinicians to provide care for mental illness and substance use disorder wherever it was needed.

She said work on that end has been seen in recent years as more providers have made efforts to integrates behavioral healthcare services within primary care settings, but more needed to be done.

Berry said criticism that has been levied at health insurers for not doing enough to comply with the intent of the parity law was misguided. “I don’t think there’s any evidence to say that that’s not happening,” Berry said.

In terms of the impact of nonquantitative treatment limits, Berry said AHIP has been consistent in calling for more clarification in the law, saying the guidance around them has been ambiguous and that it has created complexities.

“I see it as an area that because it’s ambiguous it creates confusion form everyone touched by the system.” Berry said.

Snook said ultimately, he saw healthcare providers as having a key role in the fight for parity by sharing their stories on the impact limitations of coverage have had on the health of their patients.

He said health insurers needed to reckon with the fact that lack of mental health parity was still a reality many Americans in need of mental health care face. “By not providing that level of coverage they’re not saving themselves any money and they’re really just hurting themselves,” Snook said.

http://www.modernhealthcare.com/article/20181005/NEWS/181009925

This automated indoor farm is growing so fast, it makes you think it might work

Bowery, which began distributing produce just under two years ago, is opening a new farm and ramping up its output by 30-fold.

[Photo: Bowery]

Around two years ago, the then 10-person team of Bowery, an indoor farming startup, started growing a small array of leafy greens out of what was once a shipbuilding yard in Kearny, New Jersey. Undeterred by the rather harsh post-industrial environment, the Bowery team was just looking for somewhere to set up that had a lot of space. After all, their farming system is more about the tech than it is the soil and the water and the things you might generally associate with farming. By growing produce in trays, stacked high in rooms whose temperature, lighting, and humidity is tightly controlled by a proprietary operating system, Bowery’s farming requires no soil, and instead delivers nutrients to its array of leafy greens via a hydroponic system that uses 95% less water than traditional agriculture.

Bowery certainly doesn’t look like a farm, but that, to CEO Irving Fain, is the point. “We’re excited about being able to move into these abandoned spaces in cities and create new jobs and industry,” he says. In Kearny, that’s exactly what Bowery is doing: On September 24, the startup officially unveiled its second, larger farm (the company does not disclose square footage) in a new building on the same industrial complex, which was built in 2017 as part of a larger revitalization effortin Kearny. In terms of output, the new farm is about 30 times more productive, and the startup has greatly diversified its crop output, adding bok choy, cilantro, and parsley to its original kale, spinach, and basil offerings. The startup is also expanding its distribution: It will continue selling through Whole Foods, as it already has been (at a price comparable to most of the retailer’s other greens) and also be featured on menus at Sweetgreen and Dig Inn throughout the Northeast.

[Photo: Bowery]

For an indoor farming company, this type of speedy growth is now not unprecedented–AeroFarms, another New Jersey-based indoor farming company, is also rapidly expanding–but it is a sign that perhaps, the industry is beginning to iron out the kinks that initially called into question whether it was a model that was cut out for success. Balancing the development of new technology and the associated costs along with the pressures to actually produce significant quantities of edible vegetables often proved challenging and not financially viable. Stories like that of PodPonics, an indoor farming venture that had to fold when it couldn’t raise the capital necessary to scale, often tend to dominate the narrative around the model.

[Photo: Bowery]

But while Bowery is, as Fain says, focused on its mission of upping the local supply of fresh produce grown without pesticides, it’s taking a decidedly tech-centric approach to doing so–which may be fueling its success. Before launching its second farm, Bowery raised a round of $20 million in funding from Google Ventures and General Catalyst, among others, and brought in Brian Donato, who previously managed Amazon’s automated fulfillment centers, to help build it out as the SVP of operations.

In contrast to other indoor farming startups like FreshBox, which is less concerned with building its own tech system and more focused on using whatever systems will produce the greatest yield, Bowery is all about the tech. Its automated system that manages and controls the whole farm–called BoweryOS–is entirely proprietary. In the original farm, workers still help move trays of produce, and harvest the crops when their ready, but in the sprawling new facility, humans barely need to interact with the growing plants, because the system of sensors and cameras monitors the plants and controls how much water, light, and nutrients they receive.

[Photo: Bowery]

Unlike the original farm, where all the produce was grown in one room, the new facility has multiple growing rooms. “We can essentially create different climates room by room,” Fain says. This is especially beneficial for growing a broader range of greens: Crops like cilantro grow best in hot, dry climates, while kale and bok choy thrive in cooler, wetter environments, and Bowery can now create those different climates in its growing rooms. With the upgrades to the operating system, the “farmers” at the new Bowery farm walk around with tablets, mostly in the processing area, checking to ensure that the crops are growing according to plan, but mostly focusing on post-harvest work: quality control, sorting, and packaging.

In that way, Fain says, Bowery is trying to fulfill a tech-world promise of bringing a new type of job to areas, like Kearny, still reeling from the collapse of previous industry. “We don’t require a labor force that has experience in agriculture, or really any at all,” Fain says. “We can move into a new city and essentially hire anyone, and teach them how to read the system.” Bowery decided to open its second farm in the New York-New Jersey area because its first, smaller farm couldn’t tap as much into the local labor market as they wished. They’ve now grown the team from 10 people to over 60, and plan to keep expanding as the new farm continues to ramp up operations. And starting next year, Fain says, they’ll begin eying expansion to other cities.

https://www.fastcompany.com/90239250/bowerys-automated-indoor-farm-is-growing-fast

Why Texas hospitals’ urge to merge takes precedence

Health system M&As may be necessary as insurers with greater access to capital are expanding low-cost outpatient centers into Texas to capture patients.

The proposed merger of two giant Texas health systems illustrates the escalating pressure health insurance companies are bringing to bear on hospitals threatened by narrowing provider networks and a flood of new competition from health plan­–owned outpatient providers.

Dallas-based Baylor Scott & White Health and Houston-based Memorial Hermann Health System this week said they’ve signed a letter of intent to create a 68-hospital system that draws tens of thousands of patients from Oklahoma to the Gulf of Mexico.

And even as big as they are, the deal may be necessary as even larger companies with greater access to capital are expanding low-cost outpatient centers into Texas to capture patients, as fee-for-service medicine gives way to value-based models that emphasize population health outside of the inpatient hospital.

“These two health systems are concerned about increasing market concentration amongst insurers, as well as vertical integration between providers and between insurers and providers,” said Vivian Ho, an economics professor and the director of the Center for Health and Biosciences at Rice University’s Baker Institute for Public Policy in Houston. “They are aiming to preserve their negotiating power in the midst of a rapidly consolidating landscape.”

To be sure, in general, hospitals that decide to merge say they need to consolidate to gain influence against insurance companies like Humana, which is buying providers in Texas; and UnitedHealth Group, which owns Optum, and is gobbling up doctors and clinics and expanding its MedExpress brand urgent care centers across the country. Meanwhile, drugstore and retail clinic operator CVS Health is buying Aetna, and plans to develop more healthcare services beyond the 1,100 MinuteClinics that the pharmacy chain already owns.

All three of these health insurance companies are part of an escalating trend by health plans to form narrow network health plans designed to guide patients first to their own low-cost outpatient care centers before they would go to hospitals or other providers owned by Baylor or Memorial Hermann.

With Baylor and Memorial Hermann touting their established brand, Humana has gone so far as to rebrand all of the medical care provider operations it owns in Texas and Florida under the Conviva model, hoping to attract patients to both its clinics and its insurance offerings like Medicare Advantage plans for seniors.

“We are moving to an integrated model and are building a platform that will consolidate these brands in South Florida and Texas under a one payer-agnostic physician brand called Conviva,” Humana CEO Bruce Broussard told analysts on the company’s fourth-quarter earnings call in February of this year.

“Our strategy is for Conviva to provide local depth and drive both healthcare service and Medicare Advantage growth opportunities with greater member access and engagement in health over the long term,” Broussard said. “We believe this new, simplified structure will help us to continue to build trust throughout Florida and Texas markets, improving operations while continuing to make strategic investments in the business.”

To compete against the effort of insurers to package insurance and the provision of medical care, the two Texas health systems hope to make the combined system a “national model for integrated, consumer-centric, cost-effective care.” The merger of Baylor Scott & White with Memorial Hermann will cast a wide net with more than 1,100 medical care delivery sites; nearly 14,000 employed, independent and academic physicians; and two health plans the systems own. The two systems say they “record nearly 10 million patient encounters annually.”

“Together, we believe we will be able to accelerate our commitments to make care more consumer-centric; grow our capabilities to manage the health of populations; and bend the unsustainable healthcare cost curve in the state,” Memorial Hermann President and CEO Chuck Stokes said.

Analysts say any healthcare providers that hope to compete will need “size, scale, presence, and concentration,” says Kevin Holloran, Fitch Ratings senior director and leader of the firm’s not-for-profit hospital and healthcare group. “There is always the hoped-for economies of scale, and there is also typically an underlying need to have more touch-points should population health really take off,” Holloran said.

It also sets up a battle in Texas that is perhaps a more difficult market to compete in than other areas of the country because health insurance companies and medical care providers are fighting to divvy up a smaller percentage of paying patients.

Texas has the highest rate of uninsured Americans in the country with more than 17% of the state residents who were without coverage in 2017, according to the latest U.S. Census Bureau report on the uninsured, which was released last month.

Texas is the latest of the remaining 17 states that have yet to expand Medicaid under the Affordable Care Act. Of the 28 million Americans without coverage last year, 4.8 million of them were in Texas, the 2017 census figures show.

“Texas hospitals are facing a tougher financial situation than elsewhere, because the state did not elect a Medicaid expansion under the Affordable Care Act,” Rice University’s Ho said. “The absence of those funds, combined with the highest rate of uninsured patients in the nation, may have pushed Baylor and Memorial Hermann to consider this merger.”

https://www.healthleadersmedia.com/strategy/why-texas-hospitals-urge-merge-takes-precedence

Physical Therapy Noninferior to Surgery for Some Meniscal Tears

Physical therapy appears to be nearly as effective as early arthroscopic surgery for treating nonobstructive meniscal tears in middle-aged to older adults, a study has shown.

In a randomized controlled trial, patients with degenerative, nonobstructive meniscus tears assigned to a structured program of physical therapy (PT) had similar patient-reported knee function as patients who underwent arthroscopic partial meniscectomy (APM) during a 2-year period.

The findings “are consistent with current consensus that APM should not be the first treatment in middle-aged and older patients with meniscal tears,” the investigators write.

Victor A. van de Graaf, MD, from the Department of Orthopedic Surgery, Joint Research, OLVG Oosterpark Hospital, Amsterdam, the Netherlands, and colleagues published their findings online October 2 in JAMA.

The authors of an accompanying editorial agree that the findings provide additional support for a structured, nonoperative treatment approach to managing this knee condition. They caution, however, that changing clinical practice may require the various professionals involved in meniscus tear management to develop mutually agreeable evidence-based treatment guidelines. These include orthopedic surgeons, physiatrists, physical therapists, professional organizations, and insurance companies.

To evaluate the relative effectiveness of PT and APM in this study, the investigators enrolled 321 patients aged 45 to 70 years with degenerative meniscus tears without knee locking, instability, or severe osteoarthritis. Of these, they randomly assigned 159 to receive APM within 4 weeks and 162 to receive a PT exercise protocol developed by a knee-specialized physical therapist. The PT protocol consisted of 16 half-hour sessions over the course of 8 weeks, beginning within 2 weeks of randomization. Surgery patients were only referred to PT if they did not recover as anticipated, and PT patients that did not attain the desired outcomes could extend their PT or elect APM.

The primary outcome measure was patient-reported knee function on the Subjective Knee Form of the International Knee Documentation Committee assessed from baseline and over the course of 24 months, with a noninferiority threshold of 8 points. The threshold was adopted from an earlier study that estimated the noninferiority margin from a more heterogeneous meniscus injury population “[b]ecause a minimal clinically important difference…for the [International Knee Documentation Committee] has not been defined in a population consisting only of patients with meniscal tears,” according to the investigators.

During the 2-year follow-up, mean knee function scores improved by 26.2 points (from 44.8 points to 71.5 points) in the APM group and by 20.4 points (from 46.5 points to 67.7 points) in the PT group. The between-group difference in the primary mixed model analysis of the overall effect was 3.6 points (97.5% confidence interval [CI], −∞ to 6.5) in favor of APM, which met the noninferiority criteria.

Although the between-group differences at 3 months and 6 months also showed noninferiority of PT, the effects at 12 and 24 months did not, according to the authors. “Longer follow-up will provide more details on the effect of time on the between-group differences,” they write.

Additional, exploratory outcomes included knee pain during weight bearing, general health, activity level, and osteoarthritis severity. The mixed-model analysis of the overall effects found a between-group difference of 5.9 mm (95% CI, 1.4-10.3; P = .01) in favor of APM for knee pain during weight bearing, 1.3 points (95% CI, −0.2 to 2.7; P = .08) in favor of APM for general health, no significant difference (0.04 points [95% CI, −0.3 to 0.2; P = .73) for activity level, and no significant difference for osteoarthritis progression (0.10 points more progression in the APM group; 95% CI, −0.05 to 0.26; P = .18).

Of the patients randomly assigned to PT, 29% underwent delayed APM, “demonstrating that not all patients initially treated with PT were satisfied with their results,” the authors write. “The post-hoc exploratory findings on effect modification could guide future research on the characteristics of individuals who may be less likely to respond to PT to improve their treatment options and functional outcome.”

On the basis of the study results, the authors state that PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears.

The authors of the accompanying editorial, Laith Jazrawi, MD, Heather T. Gold, PhD, and Joseph D. Zuckerman, MD, from the Department of Orthopedic Surgery at New York University School of Medicine, New York City, question whether limitations posed by the study design compromise the relevance of the findings.

“The trial used a noninferiority trial design, which is appropriate because PT may have other advantages over APM, such as lower cost, noninvasive nature, and fewer adverse effects such as surgical complications. However, the choice of the noninferiority threshold, or margin, was suboptimal,” they write, explaining that the threshold was estimated based on a “very different” patient group (older man age, multiple surgical procedure types) and shorter follow-up (preoperative and postoperative International Knee Documentation Committee score after 12 months vs 24 months).

“Given that the current randomized trial showed only a 5.8-point difference before and after surgery in the intention-to-treat, unadjusted analysis, the threshold deserves careful scrutiny and probably should have been lower to be more confident about noninferiority,” the editorialists suggest. This limitation notwithstanding, they do agree that the findings provide further support for a structured nonoperative treatment approach for meniscal tears in the setting of degenerative OA. Further, they write, “[o]rthopedic surgeons should recognize the value of this nonoperative approach and incorporate it into their treatment approach with the expectation that many patients will be treated successfully.”

The editorialists also agree with the need for evidence-based guidelines developed by a multidisciplinary consortium. “The guidelines should be focused on the best interests of the patients, rather than the clinicians, therapists, and other groups or entities who may gain from the different treatments for degenerative meniscal tears,” they write.

This study was funded by the Netherlands Organization for Health Research and Development, Zilverenkruis Health Insurance, and the Foundation of Medical Research of the OLVG, Amsterdam. Several study authors disclose multiple financial relationships with several pharmaceutical, biomedical, and research organizations. For the full list of disclosures, please see the journal website. Gold serves as the president of the Society for Medical Decision Making. The remaining editorialists have disclosed no relevant financial relationships.

JAMA. Published online October 2, 2018. Article full text, Editorial extract

https://www.medscape.com/viewarticle/902999#vp_1