For athletes who collide on the field, a neck accessory called the Q-Collar has a reassuring pitch: It’s the only medical device “proven to help protect the brain,” a claim authorized by the Food and Drug Administration.
But some of the studies offering evidence for its efficacy are now coming under scrutiny. Outside researchers have identified apparent discrepancies and errors in at least a half-dozen studies about the Q-Collar, which has endorsements from more than two dozen professional and college football, soccer, and lacrosse players.
In response, scientists who worked on the studies told The Chronicle that they are planning to fix some of their data. “While these identified errors do not change the overall interpretation of findings,” Gregory D. Myer, a researcher who oversaw many of the papers, said in an email, “we are committed to the highest standards of accuracy in reporting our research findings.”
Still, the data sleuths — Mu Yang, director of a mouse neurobehavioral facility at Columbia University Medical Center, and James Smoliga, a professor of rehabilitation science at Tufts University — are not satisfied. They say that the proposed corrections would address only a fraction of the problems they’ve found in the papers, which were all published in the Journal of Neurotrauma from 2017 to 2022.
Smoliga, a longtime critic of the Q-Collar, said that he supports athletes playing contact sports with a clear understanding of the risks. “The problem with Q-Collar is that Q-Collar is lowering the perception of the risk,” he said, “so now people are not making informed decisions.”
The apparent issues are statistical in nature: identical data for different groups of subjects, different data for seemingly identical subjects, improbable data, omitted data.
“Without a doubt,” Smoliga said, “we can say we can’t trust the data.”
‘A Pervasive Pattern’
The Q-Collar, which starts at $200 and is made by the company Q30 Innovations, has stirred debate over the decade or so it has been in development and on the market. The idea behind the thin, C-shaped collar is that by applying light pressure on the jugular vein in the neck, it increases the volume of blood in the skull and minimizes the brain’s ability to slosh around during sudden movement. David Smith, a physician in Ohio who came up with the theory and invented the device, has said he was originally looking for a way to prevent concussions, but the manufacturer eventually backed away from that claim. In February 2021, the FDA authorized it to be marketed as a device that could help protect the brain from effects associated with repetitive head impacts.
Investment in the Q-Collar has totaled more than $30 million, including $2.8 million from the U.S. Army to study whether it can help lower the risk of brain injuries in soldiers exposed to explosions. Hundreds of military members also use the device, according to Q30 Innovations. Sen. Chris Murphy of Connecticut, where the company is based, has praised its “innovative work.”
In the NFL, which is beset by the specter of concussions, the Q-Collar has “ambassadors” on the Kansas City Chiefs, Los Angeles Rams, and Chicago Bears, among other teams, according to its website. Luke Kuechly became the first player to use it in 2017, when it was still experimental, and credits it with extending his career. “It’s one of those things, I trust that it works,” the former Carolina Panthers linebacker has told ESPN. “There’s a lot of other examples of it working.”
The FDA’s authorization was based in part on a study of 284 high-school football players. Some wore the Q-Collar, some didn’t, and all of them wore an accelerometer device that measured head impacts. Images generated from brain scans, before and after the season, showed significant changes in certain parts of the non-collar-wearers’ brains versus no significant changes in the collar-wearers. But outside scientists have warned against drawing conclusions from that imaging technology. In October 2022, the FDA posted a summary of its decision with a cautionary note: “The use of imaging studies as a future indicator of brain injury has not been validated.”
Yang and Smoliga found what seemed to be other kinds of problems. In a 2017 paper that reported results from the study of football players, those who wore collars and those who didn’t demonstrated identical rates of accuracy on post-season cognitive tests, down to the second decimal point.
Myer, who was the study’s senior author when he was a professor of pediatrics and orthopedic surgery at Cincinnati Children’s Hospital Medical Center, said by email that he would submit a corrected table. But Myer, who is now at Emory University, did not address another observation of the data sleuths — that about 10 subjects appeared to be missing from one of the groups studied.
Smoliga and Yang also raised apparent inconsistencies between the 2017 article and another published in a different journal. The articles appeared to report results from the same group of people: 62 high-school football players with identically numbered subsets of collar-wearers. Yet the average number of hits and amount of gravitational forces reportedly experienced by the athletes differed across the two papers. Myer did not address this matter in his proposed corrections.
Nor did he address a seemingly similar inconsistency in a 2019 paper about SWAT team members who were exposed to blasts during a one-day training. This experiment appeared to be the same one featured in another paper in a different journal, because both reported involving 23 male SWAT team members between the ages of 31 and 68. But the sleuths calculated that the number of blasts experienced by one collar-wearing group was not mathematically compatible with those experienced by the equivalent group in the other paper.
The opposite dynamic emerged when the 2019 SWAT study was compared with a 2018 study of female high-school soccer players. Despite being about two different populations, a table with the same eight rows and 10 columns of data appeared in both. Myer said that his team had provided the wrong table in the SWAT study.
How can anybody have so many sloppy errors in so many cases?
Myer also said he would correct some data in a table in a 2021 study about high-school football and soccer players. But the sleuths identified other apparent anomalies, such as data that differed for groups of subjects that should have been identical. They also noted that a 2022 paper about football players differed in some ways from the trial protocol online — for example, it did not mention a control group of cross-country runners.
Myer said by email that most of the “questioned anomalies are derived from a misunderstanding of our analyses and data reporting.” He also said that he has “addressed each issue and question” with the Journal of Neurotrauma.
But Yang and Smoliga said that there could be even more issues in these and other papers. They noted that Myer is planning to fix an error they hadn’t spotted — a number in a sentence describing a group of collar-wearing athletes.
“It’s just a pervasive pattern of what looks like errors,” Yang said. “But how can anybody have so many sloppy errors in so many cases, and it’s the same population that you study over and over again?”
The Journal Responds
Beyond the apparent errors themselves, the sleuths are skeptical that the journal has been taking their concerns seriously. Back in May, when they wrote to the editor, they flagged one study, published in 2017, containing a table with data that seemingly differed from a text description.
But last week, four months after Yang and Smoliga sent their email, the lead author, Lt. Col. Brian Sindelar, told The Chronicle that he had not been contacted by the journal about the study, which was conducted on pigs. Sindelar, who is now a neurosurgeon in the U.S. Army, later said that he had located the original data and would be requesting a correction to some figures. (The journal’s editor in chief did not answer questions about whether it had taken any steps to investigate this study.)
Smoliga and Yang had requested that the journal refrain from discussing the study with another collaborator, Julian Bailes, citing roles of his that pose a conflict of interest. Bailes is a neurosurgeon at NorthShore University Health System, in Chicago, and a leading researcher into brain injuries in sports. He was portrayed by Alec Baldwin in the 2015 movie Concussion. Bailes is also chief medical advisor to Q30 Innovations, which he owns stock in, and an editorial board member of the Journal of Neurotrauma.
No other piece of sports protective equipment has been the subject of such intense and objective research as the Q-Collar.
Bailes said by email that he had not been aware of any concerns about the studies in question or involved in any discussions about them until he was contacted by The Chronicle, and had not served as a journal editor or reviewer for any of them. He said that he is one of 30-some advisers to Q30 Innovations, is unpaid, and is contacted three or four times a year for his insights.
Smith, the Q-Collar’s inventor, is a collaborator on four of the six studies flagged by Yang and Smoliga. Smith said by email that he was not involved with the study’s design, data collection or analysis, and that his role was “to bring novel insights into how to mitigate the physics of brain injury.”
All six studies were paid for by Q30 Innovations. Gary Greene, the company’s general counsel, said that it played no role in the study’s development, nor did it draft or edit the articles. In an email, he said that Q30 Innovations supported efforts to correct any mistakes, saying, “No other piece of sports protective equipment has been the subject of such intense and objective research as the Q-Collar, since nothing like it has ever been evaluated by the FDA.” He added that there have been no adverse events reported in the years that the Q-Collar has been tested and used by tens of thousands of athletes.
Without specifying, Greene also alluded to being aware of “a few vocal critics of the Q-Collar,” and said that “none of those individuals have performed any of their own relevant research on methods of reducing risk or severity of traumatic brain injuries.”
So far, the Journal of Neurotrauma has resisted the data sleuths’ calls for an independent investigation.
On September 8 — hours after Yang posted on X about some of the apparent problems she’d found — David L. Brody, the journal’s editor in chief, told her and Smoliga by email that Myer had “responded with detailed descriptions of their rationales, provided original data files, and performed re-analyses of their data,” and was planning to submit corrections. In the interest of “full transparency,” Brody proposed that Yang and Smoliga submit a “brief as possible” letter, to which Myer and his colleagues could respond. If the pair wanted to address the 2017 study led by Sindelar, they could draw up a separate letter.
Smoliga pushed back, arguing that he and Yang could not address the “wealth of issues” in a letter, and that Myer’s team should not be allowed to self-investigate and self-correct without independent verification or oversight. “We remain deeply concerned,” he wrote, “about the objectivity and rigor of the investigative process that seems to have unfolded.”
But later in the week, Brody informed them that the journal would be taking no other action. He wrote that Smoliga and Yang would later “have an opportunity to re-analyze the data yourselves” — and “if this is still not satisfactory, you may, of course, reach out to the authors’ home institutions to request additional investigations.”
Yang and Smoliga told The Chronicle that they couldn’t trust that the data provided to them would be authentic. “After being accused of letting the alleged self-investigate and self-correct, Brody now is asking us to investigate the alleged,” Yang wrote. “It is like a police chief telling the bank staff and bank robber to get in the ring, while sitting back.”
When The Chronicle asked Brody why the journal was not investigating the issue on its own, he replied, “We’ll be happy to provide comments at an appropriate time. We’re all trying to move forward in a fair and balanced fashion.” He referred questions to representatives at the publisher, Mary Ann Liebert, who did not respond.
