Monday, May 6, 2019

Making the case for primary care-led, federally funded clinical practice guidelines

Talk about throwing down the gauntlet. In a provocative editorial published last year in Circulation: Cardiovascular Quality and Outcomes, Dr. John Ioannidis, who in 2005 shocked the scientific research community with his article "Why Most Published Research Findings Are False," took aim at medical professional societies authoring clinical practice guidelines and disease definition statements. He observed that despite notable progress in improving the trustworthiness of guidelines since the 2011 Institute of Medicine report Clinical Practice Guidelines We Can Trust, guideline panels continue to be plagued by financial conflicts of interest, lack of methodologist involvement, and domination by specialists "who have overt preferences (even without overt conflicts)."

Recent studies support Dr. Ioannidis's points. One study found that more than half of authors of gastroenterology guidelines received industry payments between 2014 and 2016. Another study of the top 10 highest-revenue medications of 2016 determined that more than half of authors of related guidelines had financial conflicts of interest, many of which were not disclosed in the journal publications. Finally, a study evaluating levels of evidence supporting U.S. and European cardiology guidelines from 2008-2018 found that only 8 to 14% of recommendations were supported by evidence from multiple randomized, controlled trials (RCTs) or a single, large RCT, while 42% and 55% of U.S. and European recommendations, respectively, were based on expert opinion only. In sum, even when guideline authors weren't on the take, eminence-based medicine trumped evidence-based medicine.

Poorly conducted professional society guidelines don't benefit front-line clinicians, but Ioannidis noted that they do have other benefits:

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?

A way to move beyond the production of clinical practice guidelines that are essentially "industry-friendly opinion pieces" is to centralize development efforts within government health agencies, or publicly-supported independent panels such as the U.S. Preventive Services Task Force (USPSTF). A recent review of 421 clinical practice guidelines for noncommunicable diseases in primary care concluded that guidelines developed or financed by governments were substantially more likely to be rated high-quality according to the AGREE-II tool than those developed by others. Dr. Michael LeFevre, a family physician colleague and former USPSTF chairman, suggested in a 2017 editorial that public investment is "essential" to producing trustworthy guidelines:

A substantial and consistent funding stream should be available for the development of clinical practice guidelines and should be awarded competitively through a process similar to research grant funding. The logical place for this funding to occur is through the Agency for Healthcare Research and Quality (AHRQ). ... The topic, guideline development panel, and methodology would be part of a competitive grant proposal. ... Proposals receiving funding would be assigned an evidence-based practice center (EPC) to work with the guideline development panel to provide an independent systematic review of the literature. The [EPC] program would need additional funding, but the focus of the efforts would shift to be channeled to producing reviews that would be assured of being used in the development of a clinical practice guideline we can trust.

Unfortunately, funding for AHRQ has always been politically precarious, and the closure of the National Guideline Clearinghouse last year does not bode well for starting a major new program to support guideline development and assessment, even as AHRQ-supported researchers continue to break new ground with the National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards (NEATS) instrument.

And what about the problem of intellectual bias - being unable to see beyond the scope of one's own limited clinical experience to evaluate evidence impartially? Dr. Ioannidis first proposed having methodologists and patients write guidelines, with content experts serving as non-voting reviewers. Alternatively,

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.

As a family physician who has served on guideline panels for cardiology (Pharmacologic management of newly detected atrial fibrillation) and otolaryngology (Cerumen impaction) topics, I find a great deal of merit in the latter approach, and a similar effort led by Dr. Ray Moynihan and primary care colleagues to reform disease definitions so that potential harms of expanding diagnostic criteria are considered along with the benefits for chronic conditions such as hypertension. It's no accident that the USPSTF has long been considered an exemplar of guideline development: the panel's members are all primary care clinicians or methodologists, and have one of the strictest conflict-of-interest policies in the field. Their recommendations don't make everyone happy or anyone wealthy, and that's most likely a good thing for patients.


This post first appeared on The Daily Physician.