Cardiology societies take few things with more seriousness than their guidelines. But the whole process needs a shake-up, according to policy and research contrarian John Ioannidis, MD.
In a viewpoint in , he questioned whether cardiovascular guidelines "homogenize biased, collective, and organized ignorance" through use of predominantly "insider" experts as authors.
Ioannidis, of California's Stanford University, proposed that professional societies still fund and produce guidelines and disease definitions and such, but consider replacing their specialists with more impartial stakeholders for these documents.
Beyond largely successful efforts to minimize financial conflicts of interest with industry, the modest move to include methodologists, nonphysicians, patients, and community representatives hasn't actually allowed them to "exert much influence when embedded within a dominant majority of vocal specialty experts," he said.
Turning the tables so that outsiders write the documents and then specialists comment on them would eliminate the reason to be biased in favor of the specialized practices under discussion, as their own services and payments would not be at stake, Ioannidis wrote.
As it stands, not only do the societies rely heavily on industry support, he noted (citing industry as the source of 20% of the American Heart Association [AHA] budget and 77% of that for the European Society of Cardiology [ESC]), but industry makes the interventions that procure much of the money in the specialty.
"Having professional societies and their specialist members author both the main guidelines and the performance measures and appropriate use criteria is actually increasing the risk of one-sided views (if there is stacking of opinions), and of escalating costs and harms," he wrote, predicting "there would be far more recommendations to cut back on wasteful services, if high-profile professional specialists who offer these services were disentangled from authoring these documents."
The AHA said it "strongly disagrees" with Ioannidis's proposals and reiterated the rules it has in place to minimize industry influence on guidelines.
"The American Heart Association and American College of Cardiology both agree on the importance of preventing even the perception of bias and/or industry conflict. We are working together to ensure our rules for guideline writing group members remain strong," the AHA said in a statement to ѻý.
The American College of Cardiology said in a statement from its president, C. Michael Valentine, MD, that it is committed to "the very highest ethical standards in all of our activities" as well as to using cardiologists in development of clinical policy: "Guideline committees include multiple members of the cardiovascular care team, not just cardiologists, but they all have one thing in common -- they are at the forefront of cardiovascular medicine and the most appropriate and qualified people to develop guidelines to meet the needs of practitioners and to improve patient care."
In an responding to Ioannidis in the journal, John Spertus, MD, MPH, of Saint Luke's Mid America Heart Institute in Kansas City, Missouri, and Sidney Smith, MD, of the University of North Carolina at Chapel Hill and a past president of the AHA, argued that guidelines have not incorporated cost of care, by intent, "due largely to a lack of cost effectiveness analyses and changing costs for specific therapies, rather than a nefarious effort to enrich the profession's income."
Spertus and Smith also emphasized the importance of "professionals familiar with treating patients" on guideline-writing committees.
"Ongoing efforts to improve the composition of writing committees and their methodologic rigor are critical but doing so without the experience and expertise of the professional societies is misguided," the commentary concluded.
A statement from ESC immediate-past-president Barbara Casadei, MD, DPhil, agreed: âIt would be a mistake to equate specialist knowledge to bias (or lack of it as synonymous to fairness).â
She acknowledged that âmedical societies may have leaned too much on experts who have previously delivered well on this very time-consuming task,â but concluded, âThis is what needs to be addressed â rather than dispose of a process that has been carefully developed over many years and is much valued by all.â
Brahmajee Nallamothu, MD, editor-in-chief of the journal, likewise defended cardiologists' key role on such documents: "The complexity of medicine is evolving so rapidly that it is impossible for any of us to keep abreast of new advances. Clinical specialists ... not only understand the evidence behind guidelines but have the hands-on wisdom and skills required for their practical application."
However, he said his opinion didn't override the importance of having this discussion: "This is not just a theoretical debate as the role of clinical specialists has recently consumed competing hypertension guidelines," he , praising the independence the AHA provided his journal "to publish this work, despite its potential criticism of a process (i.e., the guidelines) that the American Heart Association highly values."
Primary Source
Circulation: Cardiovascular Quality and Outcomes
Ioannidis JPA “Professional societies should abstain from authorship of guidelines and disease definition statements” Circ Cardiovasc Qual Outcomes 2018; DOI: 10.1161/CIRCOUTCOMES.118.004889.
Secondary Source
Circulation: Cardiovascular Quality and Outcomes
Nallamothu BK “Professional societies, clinical specialists, and guidelines” Circ Cardiovasc Qual Outcomes 2018; DOI: 10.1161/CIRCOUTCOMES.118.005201.