Research in Orthopedics: Managing Conflicts of Interest to Maintain Objectivity and Integrity of ResultsWritten by Laura Miller | November 28, 2011
A team of prominent orthopedic surgeons and researchers recently published the largest systematic literature review on joint chondrolysis in the Journal of Bone and Joint Surgery examining the potential causal factors for the cartilage pathology along with its differential diagnosis. Chondrolysis is a condition that occurs most often after an arthroscopic procedure that somehow results in cartilage destruction in the joint. Treatment for such global loss of articular cartilage often requires a total joint replacement. The study, led by Matthew T. Provencher, M.D., an orthopedic surgeon at the Naval Medical Center San Diego in San Diego, CA, determined that the causes for chondrolysis were multifactorial, meaning no single factor could be isolated as causing the disorder.
The article comprehensively examined all published cases of chondrolysis in the global literature including reports in the hip, shoulder, knee, ankle and elbow. "We were able to synthesize a lot of data from six decades of resources and we let the data guide the final conclusions," says Dr. Provencher. "We performed our research to better define the phenomenon of chondrolysis, improve the recognition of chondrolysis, and ultimately, improve patient care." The research was not funded by any source and the authors performed all of their work during their free time. Despite this, some of the authors were served subpoenas and deposed by lawyers seeking to investigate whether their study results were tainted by potential influences from outside funding sources.
JBJS has also been questioned by the industry and legal community on multiple occasions about the decision to publish research on chondrolysis, which has made it difficult for the editors and peer-reviewers to publish on this topic using established journal protocols without being forced to navigate various stressors.
"In the case of chondrolysis, some surgeons avoided the issues and tried to sweep them under the rug so they weren't pulled into the litigation process," says Anthony A. Romeo, M.D., head of shoulder and elbow surgery at Rush University Medical Center in Chicago. "Their information from their respective practices may have been valuable to finding the problem and identifying corrective solutions quicker."
The authors of the JBJS study titled "Joint Chondrolysis" — Dr. Provencher, Dr. Romeo, Daniel J. Solomon, MD, of Marin Orthopedics and Sports Medicine in Novato, Calif., Maryam Navaie, Dr.P.H., President and CEO of Advance Health Solutions based in La Jolla, Calif., and graduate student Jessica C. Smith, BA — discuss conflicts of interest in orthopedic studies and how surgeons and their researcher collaborators can maintain research objectivity and integrity.
Recognizing conflicts of interest
Conflict of interest is defined by the factors influencing a researcher's work which could have an impact on the synthesis and presentation of information. Every researcher has conflicts of interest, with potential conflicts including institutional biases and professional relationships driving interest in a particular topic. The biggest and arguably most controversial conflict of interest is the funding source for the research.
"Quality research requires much time, effort and funding. Therefore, the conflict of interest occurs primarily with the potential sources for funding," says Dr. Romeo. "This is particularly true for scientists who are physicians because our primary source of work and income comes from clinical and surgical patient care. If we are dedicated to performing research, we need to subtract time away from our clinical and surgical work to apply our time, effort and thoughts to our research. We look for outside funding to off-set our own loss of revenue and perform fiscally responsible research."
In recent years, medical journals and professional meetings have required surgeon researchers to disclose financial relationships with benefactors, which frame how others regard their work. Results from independently funded studies may have more weight than an industry-sponsored study in terms of changing how orthopedic surgeons conduct their practices.
"With disclosures, people are more aware about what is happening out in the industry," says Dr. Solomon. "You can't have good research without others being able to look up and see what influences the results of the research."
Funding for orthopedics research has traditionally come from government grants or the medical device industry. However, a new generation of researchers is now receiving funding from other sources, including law firms arguing cases against a particular surgeon, procedure or device. "Now we are seeing more orthopedic studies funded directly or indirectly by the law firms, and those parties have tremendous vested interest in winning the cases for their clients by influencing publication of skewed results to support their legal arguments," says Dr. Navaie. "That conflict is important to know."
Conflicts of interest are easy to pinpoint when they involve funding; they are harder to parse out when the research is independent.
"As long as human beings are involved in research, there is going to be bias" says Dr. Romeo. "That's why we have a very structured mechanism to improve the quality of the evidence that we are presenting from our research. There is a hierarchy with regards to the quality of evidence with randomized, controlled studies being ideal. However, we recognize that under certain circumstances, such as studies on chondrolysis, it is neither ethical nor feasible to conduct clinical trials so other types of epidemiologic studies need to be employed. In more methodologically robust studies, physicians and patients are less likely to inflict bias on the scientific work and those studies are more likely to stand the test of time."
Dr. Romeo urges orthopedic surgeon researchers to conduct high-level, evidence-based studies for better scientific analysis of the literature.
What orthopedic research stands to lose
Some of the authors of "Joint Chondrolysis" say they would not have undertaken the research if they had known the extent of unjustified scrutiny that would be placed upon them.
"There is so much controversy surrounding chondrolysis," says Dr. Solomon. "People are questioning our research process and it makes me not want to do it anymore. It takes time out of my private practice. I do it because I love it and I think it is helpful for patients. I knew there would be scrutiny, but I never really thought about lawyers getting involved. If everyone went through this, there would likely be very few surgeons willing to do research on chondrolysis unless they were completely protected. The disincentives for becoming involved are substantial."
Dr. Romeo says the threat of litigation may have already had an impact on chondrolysis care, as surgeons and researchers who noticed adverse events may have chosen not to undergo studies about them because of the growing controversy.
"If a surgeon finds out there are concerns about a product from a legal prospective, he or she is highly unlikely to investigate the experience in his or her practice or look at basic science research related to the product because of intimidation from outside sources," Dr. Romeo says. "There were several physicians who used thermal energy and intra-articular pain pumps for the shoulder and knee before there was published research on these factors as potential etiologic contributors to chondrolysis. Information about these products could have been better articulated throughout our community if there wasn't a threat of legal backlash."
No one knows this better than Ms. Smith, whose graduate thesis is on chondrolysis. She is a co-author on the JBJS publication and describes herself as the most junior person contributing, yet she still received a subpoena.
"If your work is even tangentially related to a case, you could be brought into it," she says. "Even though I didn't do anything wrong and I wasn't paid for my thesis research as the lawyers believed I was, it was still an uncomfortable and distressing process for me to go through. The ultimate effect is intimidation; now it's a calculation I make about the work I do. I ask myself: Is this research something that could bring me into a controversy I don't want to be a part of?"
When choosing research projects, orthopedic surgeons must consider how their outcomes might be viewed by their bosses, patients and colleagues; straying away from controversial topics might be viewed as justified and necessary by some surgeons to maintain a good practice and reputation without the stresses that accompany research on emerging and heavily scrutinized disorders.
Why research is important
Whether independent or industry funded, orthopedic research is incredibly important to the advancement of patient care. All published research has the potential to change the way surgeons conduct themselves in their practices, according to the positive or negative results, and it's the responsibility of the researchers to ensure their results foster good outcomes.
"We have to have a personal sense of integrity with our research and keep reminding ourselves that the information we are providing will be used by others in the care and management of our patients," says Dr. Romeo. "There should be a moral and ethical responsibility among researchers to do their best to present the evidence as cleanly as possible and to continue to design studies that yield quality evidence meaning the best possible results, considering the conditions being investigated."
All studies begin with a hypothesis, and in some cases the final results don't support the hypothesis. Dr. Romeo says surgeons need to have the opportunity to present their data even if it is contrary to the hypothesis without repercussions from a funding source or another outside influence, such as the fear of litigation.
"We have to be careful not to take the information gleaned from our research and impose an interpretation on it that is overreaching and incorrect," he says. "That's where the human element and ethical integrity of the researcher comes into play. It's important for orthopedic surgeons to maintain this integrity so we can trust our peers to get the information we need for providing the best care to our patients. The ultimate result of the research we are looking for is the ability to answer this critical question: What is the best way to treat the patients I have in front of me?"
Beyond the immediate influence on a physician's practice, the results of research projects can have far-reaching consequences if the studies are cited in regulatory or payor guidelines. Payors and regulatory bodies, such as the U.S. Food and Drug Administration, look to the published evidence in the literature to establish appropriate treatment guidelines for safety and efficacy as well as reimbursement. Therefore, a study with a particular bias can unfairly impact how surgeons are able to provide care or be compensated for their services.
For example, the Milliman Care Guidelines recommend against performing vertebroplasty for patients with degenerative disc disease (DDD) based on studies questioning its efficacy, including one finding it has no better results than a placebo procedure. However, multiple other studies report vertebroplasty as a better solution than non-surgical treatment. Despite the positive vertebroplasty studies, some payors decided to stop reimbursing for it when the only indication was DDD. Dr. Navaie worries a similar scenario could happen for joint arthroscopy if all research isn't considered equally.
"Although the percentage differs depending on the joint, in general, on average, 80 percent of chondrolysis cases are secondary to arthroscopy so there are critics who are saying arthroscopic surgery isn't safe despite strong evidence to the contrary," says Dr. Navaie. "This line of argument has important implications regarding access to care issues for patients. We have to look at the etiological factors contributing to chondrolysis in a comprehensive and systematic manner. If we take away all the hoopla surrounding pain pumps, that doesn't mean chondrolysis will go away because a significant number of cases have occurred when pain pumps weren't used."
In addition to limiting the use of pain pumps, the authors of "Joint Chondrolysis" have recommended surgeons avoid over-tightening the shoulder, eliminate the use of prolonged exposure to heat, avoid fluids of extreme temperatures and position implants appropriately to prevent chondrolysis.
Maintaining integrity in the peer-review process
In addition to questioning the authors of "Joint Chondrolysis" about their research conflicts, lawyers have demanded to become privy to information between the authors and JBJS reviewers.
"One of the challenges we had was that lawyers wanted access to our manuscript before it was published and the privileged reviewer notes," says Dr. Navaie. "At that point, the manuscript was owned by the Journal under copyright transfer. We had to site appropriate laws that said we couldn't release that information because it was not ours, [and] therefore unlawful."
If the interactions are released, lawyers could bring reviewers into a case as well. The majority of peer reviewers for medical journals aren't compensated for their work and are free to accept or reject review requests, so they may decide not to review controversial studies if it means being brought into a court case.
"If reviewers might get litigated against based on what they say in their reviews, we will lose quality peer reviewers. We cannot allow this to happen because ultimately, the consequences will be terrible for patients whose doctors often rely on the literature to guide best practices" says Dr. Navaie.
Medical journals also stand to lose the autonomy associated with peer-review governance if non-medical professionals are able to intervene in the process. "Peer-review means review from individuals who are considered to have the same medical expertise and background," says Dr. Romeo. "Reviewers analyze and constructively criticize the work that is being presented. If you have a non-medical person in the process, [his or her] background could potentially distort the information that is going to be ultimately published."
Dr. Provencher echoes this statement. "In the medical profession, we want the peer review process to maintain its integrity and continue to provide us with the most meaningful and impactful data to help make the best patient decisions," he says. "It's really the patients who are going to benefit from the research. This point needs to be at the forefront of our minds."
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