Professional Societies Should Abstain From Authorship of Guidelines and Disease Definition Statements
Guidelines and other statements from professional societies have become increasingly influential. These documents shape how disease should be prevented and treated and what should come within the remit of medical care. Changes in definition of illness can easily increase overnight by millions the number of people who deserve specialist care. This has been seen repeatedly in conditions as diverse as hypertension, diabetes mellitus, composite cardiovascular risk, depression, rheumatoid arthritis, or gastroesophageal reflux.1 Similarly, changes in prevention or treatment options may escalate overnight the required cost of care by billions of dollars.2 Should the specialists of the respective field be the developers for such influential articles?
Many influential professional society documents are written exclusively by insiders. Joining such guideline panels is considered highly prestigious and allocation of writing positions is a unique means to advance an expert’s visibility and career within the specific medical specialty. The number of authors plus collaborators in the masthead of these influential documents sometimes exceeds 100 (eg, 118 for the 2014 European guidelines on myocardial revascularization). Hundreds and thousands of designated guideline coauthors share in the society-wide power game across a large portfolio of guidelines and statements that improve, fine tune, or manipulate disease definition and management. Tens of thousands of society members then cite these articles. This creates a massive, clan-like, group self-citation network.
Eight of the 15 most-cited articles across all science published in 2016 are medical guidelines, disease definitions, or disease statistics (Scopus search, May 11, 2018). Cardiovascular medicine and its powerful professional societies (European Society of Cardiology, American Heart Association, American College of Cardiology) have the lion’s share. Cardiovascular experts represent almost half of the most-cited scientists in Clinical Medicine according to Clarivate Analytics (Web of Science). Most (not all) citation superstars get bulk citations by coauthoring guidelines, industry trials, and nonsystematic expert reviews. Stardom is the interwoven product of guidelines and industry links (Table). Industry trials nurture opinion leaders who then solidify their clan power authoring guidelines that serve the industry.
|Name of Author||Articles that have >2000 citations||Most-Cited Article Citations||Type|
|Abraham, William T||3||3||0||5355||Guideline|
|Adams, Cynthia D||5||0||0||4115||Guideline|
|Albert, Nancy M||0||0||0||1551||Guideline|
|Angiolillo, Dominick J||0||0||0||1167||Industry trial|
|Anker, Stephan D||3||0||0||8094||Guideline|
|Antman, Elliott M||15||3||1*||6604||Guideline|
|Avezum, Alvaro||0||2||1*||10 812||Other*|
|Fagard, Robert H||12||0||1*||8809||Guideline|
|Feldman, Ted E||1||1||0||3344||Industry trial|
|Filippatos, Gerasimos S||17||0||0||19 293||Guideline|
|Fonarow, Gregg C||4||0||0||6295||Guideline|
|Fox, Keith AA||3||0||0||6604||Guideline|
|Halperin, Jonathan||8||1||0||6368||Industry trial|
|Harrington, Robert A||0||1||0||4953||Industry trial|
|Hochman, Judith S||5||0||1||4115||Guideline|
|Hohnloser, Stefan H||2||2||0||5686||Industry trial|
|Holmes, David R||0||2||1||5134||Industry trial|
|Hunt, Sharon Ann||9||0||0||5101||Guideline|
|Husted, Steen E||1||1||0||4953||Industry trial|
|Wallentin, Lars C||4||3||0||8952||Industry trial|
|Wang, Thomas J||0||0||1||2347||Other|
|Webb, John G||0||2||1||4509||Industry trial|
|White, Harvey D||2||0||2||6604||Guideline|
|Wiviott, Stephen D||0||4||0||5495||Industry trial|
|Wood, David A||1||0||0||8132||Guideline|
Professional society journals also benefit. For example, European Society of Cardiology guidelines are published in the European Heart Journal and of the 20 most-cited articles of this journal in the past decade, 19 are guidelines and 1 is an article on definition of myocardial infarction (Web of Science search, May 11, 2018). The impact factor of the European Heart Journal increased from 2.137 in 1997 to 20.212 in 2016 (the highest among cardiology journals). In the US, similarly, most of the top-cited articles in Circulation are disease statistics, disease definitions, and American Heart Association/American College of Cardiology guidelines. Nine of the 10 articles contributing the most to the 2016 impact factor of European Heart Journal and 8 of the 10 articles contributing the most to the 2016 impact factor of Circulation are guidelines, disease definitions, or statistics.
Thus, these guidelines writing activities are particularly helpful in promoting the careers of specialists, in building recognizable and sustainable hierarchies of clan power, in boosting the impact factors of specialty journals and in elevating the visibility of the sponsoring organizations and their conferences that massively promote society products to attendees. However, do they improve medicine or do they homogenize biased, collective, and organized ignorance?
Well-conducted unbiased guidelines can be useful.3 However, most published guidelines have one or more red flags that either make them overtly unreliable or should at least raise suspicion among potential users.4 The list of red flags includes sponsoring by a professional society with substantial industry funding, conflicts of interest for chairs and panel members, stacking, insufficient methodologist involvement, inadequate external review, and noninclusion of nonphysicians, patients, and community members.4 Much of the prior discussion has focused on the presence of financial conflicts among panel chairs and members.5,6 After mounting pressure from the 2011 Institute of Medicine report,5 several societies have succeeded in part to ameliorate the composition of their chosen panels to avoid florid financial conflicts and preclude direct industry funding in guideline development. They have also included some methodologists. In recent guidelines, cardiovascular societies have tried to include more primary care physicians, nurses, and patients to their panels. However, it is unclear that such representatives can exert much influence when embedded within a dominant majority of vocal specialty experts. Prioritizing more the role of methodologists with expertise on evidence assessment and biostatistics and excluding content experts with conflicts (both financial and nonfinancial)7 is still uncommon across medical specialties. Moreover, stacking of the panels with specialists who have overt preferences (even without overt conflicts) is more difficult to avoid.4
Some professional societies are behemoth financial enterprises. Massive producers of medical guidelines and of disease definitions tend to be the largest financial players, again with cardiology being the leading example. For example, the annual American Heart Association budget in the fiscal year 2016–2017 was $912 million, 20% of which came from corporate support.8 Massive industry funding is common. For example, 77% of the 60 million Euro annual income of the European Society of Cardiology comes from the industry.9 Efforts are made to minimize the influence of this funding.7 However, securing objectivity is difficult when industry-manufactured interventions also procure much of the specialty income. Would a society advise its members to change jobs, if evidence proved their medical services a waste?10,11
Appropriate use criteria and performance measures may help decrease cost and unnecessary procedures. However, these criteria align with what potentially biased guidelines of these professional societies already endorse. An overspecialized worldview is a major disadvantage in making sound recommendations. Specialists cannot compare their merchandise against the merchandise of other healthcare providers. However, diverse specialists and societies compete for the same pie of healthcare resources.
Proponents of evidence-based medicine have recognized early the need to be critical toward guidelines, for example, the Journal of the American Medical Association User’s Guides series offered guidance on this since 1995. Yet evidence-based medicine and professional societies have had a mutually suspicious relationship. Grading of Recommendations Assessment, Development and Evaluation (http://www.gradeworkinggroup.org and http://www.gradeworkinggroup.org/#pub), an important initiative on evidence appraisal, has tried to improve standards of guidelines and secure their objectivity and methodological strength. However, most cardiology professional societies refrained from joining the Grading of Recommendations Assessment, Development and Evaluation working group, when others, such as the journal Chest guidelines and the Canadian Cardiovascular Society guidelines, did.
Guideline development also needs to consider the sociopolitical context. Different countries vary on whether guidelines are entrusted to government or professional societies. In the United Kingdom, the National Institute for Health and Clinical Excellence is authorized by the government to consider both efficacy and cost-effectiveness. Conversely, in the United States, the US Preventive Services Task Force is convened by the Agency for Health Research and Quality, but most powerful guidelines are issued by professional societies; these typically place less attention on cost containment. With skyrocketing healthcare expenditures, largely cost-unconscious guidelines make little sense.
An alternative approach to the current situation would be to avoid having specialists assume any major role in guidelines that pertain to their own fields. The most definitive way to materialize this approach would be to entirely ban professional societies from the development of guidelines. This is, however, impossible to impose. A more realistic solution would be to have professional societies and their members abstain specifically from writing their own guidelines. Instead of having mostly or exclusively specialists write the guidelines and occasional nonspecialists consult or comment on them, guidelines could be written by methodologists and patients, with content experts consulted and invited to comment. This approach has been proposed also for systematic reviews and meta-analyses that synthesize the evidence feeding into guideline development.12
Another possibility is to recruit also to the writing team medical specialists who are unrelated to the subject matter. Involvement of such outsiders (eg, family physicians involved in cardiology guidelines) could be refreshing. These people may still have strong clinical expertise, but no reason to be biased in favor of the specialized practices under discussion. They may scrutinize comparatively what is proposed, with what supporting evidence, and at what cost. Devoid of personal stake, they can compare notes to determine if this makes sense versus what are typical trade-offs for evidence and decisions in their own, remote specialty. For example, while insider specialists may be willing to endorse an effective but highly expensive drug or device, outsiders may see more easily that this intervention is outrageously expensive. Outsider specialists may improve the calibration of recommendations. Knowledgeable field experts may be uncalibrated, that is, all their recommendations may be stronger or proposed for wider use than what a nonspecialist would propose. What may seem crucially important to a field expert, may appear as minutiae to a less personally involved outsider.
Outsider specialists who serve as guest guideline writers may also be instructed upfront to mentally envision the following trade-off: any extra budget required for making more aggressive use of services and interventions in that remote specialty that they scrutinize as guests would have to be deducted from the resources dedicated to their own specialty. This mental exercise is realistic because the total resources available for health care are not infinite. Methodologists, patients, and different field specialists add to guideline teams more methodological rigor, patient-centeredness, and impartiality.
Professional societies should consider disentangling their specialists from guidelines and disease definitions and listen to what more impartial stakeholders think about their practices. Professional societies could still fund these efforts without their own experts authoring them.
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