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Clinical Guidelines From North American Specialty Societies Often Biased, Have Conflicts of Interest
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Clinical practice guidelines issued by specialty societies in North America often call for greater use of services associated to their own specialties, and at times contradict European guidelines and those from independent North American groups, according to a commentary published in the Canadian Medical Association Journal.
In addition, the authors wrote that specialty organizations from nations with fee-for-service health care systems, such as the United States, often recommend more intensive diagnostic and treatment guidelines. This constitutes a conflict of interest that, along with specialty bias, is rarely disclosed in the guidelines, they wrote.
“Regardless of country of origin, physicians often recommend procedures and treatments that they are trained to provide, a phenomenon known as ‘specialty bias,’” Ismail Jatoi, MD, PhD, of the University of Texas Health, and Sunita Sah, MD, PhD, of Cornell University, wrote. “This may explain why medical specialty societies frequently issue guidelines calling for greater use of health care services linked to their specialties, thereby exacerbating overdiagnosis, overtreatment and increasing health care costs.”
In their commentary, the authors included four examples of such biases and conflicts. In one example, the National Comprehensive Cancer Network, which is based in the United States, included 25 urologists in its 32-member panel to draft clinical guidelines for prostate cancer. According to Jatoi and Sah, the guidelines recommend prostate-specific antigen screening for healthy men aged 45 years and older.
This is at odds with the guidelines issued by the Canadian Task Force on Preventative Health Care and the European Society of Medical Oncology, both of which recommend against prostate-specific antigen screening for men of all ages. The Canadian Task Force on Preventative Health Care included zero urologists on its nine-member panel, while the European Society of Medical Oncology had one urologist out of four members.
“Evidence-based clinical practice guidelines can improve health care delivery,” Jatoi and Sah wrote. “Yet specialty bias and fee-for-service conflicts of interest threaten their validity and may lead to unnecessary overuse of health care services. More is not necessarily better in medicine; if anything, patient outcomes may be worse the more ‘care’ they receive. Every medical test, procedure and treatment adds risk against potential benefit, and some may lead to more harm than good.”
According to the authors, organizations that issue clinical guidelines should disclose specialty biases and fee-for-service conflicts of interest as “an important first step.”
“Clinical practice guideline panels should be multidisciplinary in composition, independent of the governing bodies of medical specialty societies, and strive to reduce fee-for-service conflicts of interest, Jatoi told Healio Rheumatology.
Specialty societies should also acknowledge “that they serve the interests of their memberships, which are not always aligned with the public’s interests,” Jatoi and Sah added.
“Guideline panels should ideally contain individuals with expertise in epidemiology, biostatistics and clinical trial methodology, along the lines of those assembled by the Canadian task force, United States Preventive Services Task Force and [the UK’s National Institute for Health and Care Excellence],” Jatoi and Sah wrote. “Specialty societies should do the same lest guidelines from independent bodies become the only ones deemed to meet adequate standards.” – by Jason Laday
Disclosure: Jatoi and Sah report no relevant financial disclosures.
Perspective
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David A. McLain, MD, FACP, FACR
Gone are the days when a physician could select a test, procedure or therapy without regard to clinical practice guidelines — at least for the more expensive tests and therapies — and at any cost, to be practicing evidence-based medicine. Following the recommendations of this commentary may also take the specialty societies out of the voting role for practice guidelines.
Are practice guidelines, ‘guidelines’ or are they the ‘rule of law’? Many insurance companies, PBMs, and insurance consultants view them as ‘law’. Practice guidelines are issued by different medical groups, specialty societies and agencies from different geographic areas. This commentary notes that after reviewing the same evidence and from the same clinical trials, the guidelines issued by different medical panels can be at odds with each other.
The authors argue that the differences among the various guidelines may have to do with vested financial interests, ‘specialty bias’, and even the potential for litigation — noting that the U.S. is a litigious society. They give four examples of clinical practice guidelines to illustrate their point. None of them were in rheumatology, but this commentary relates to the development and propagation of all clinical practice guidelines.
The authors feel there is a conflict of interest for clinicians to suggest costly care when less expensive or no care would suffice; they also conclude that the fee-for-service system in the U.S. favors procedures while the UK National Health System does not. Additionally, the authors suggest that guideline panels should be multidisciplinary in composition, independent of the governing bodies of specialty societies, and aim to reduce fee-for-service conflicts of interest.
They further recommend a guidelines panel containing epidemiology, biostatistics and clinical trials methodology, similar to the Canadian task force, US Preventive Services Task Force, and UK’s National Institute for Health and Care Excellence, warning that specialty societies proposing guidelines without these standards may find their role supplanted by these independent groups.
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Peter R. Carroll, MD, MPH
The makeup of the interdisciplinary panels behind the recommendations in the NCCN Clinical Practice Guidelines in Oncology is one of their greatest strengths. The NCCN Guidelines are the recognized standard for clinical policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine. Numerous independent studies have found that adhering to their recommendations results in better outcomes for patients with cancer.
The NCCN Guidelines panels are carefully chosen to reflect diversity in experience, geographic location, patient population and medical specialization. Each panel includes representatives from the 28 leading academic cancer centers that comprise NCCN, and include epidemiologists, internists, medical oncologists, pathologists, radiation oncologists, surgeons, urologists (where applicable) and patient advocates whenever possible, among other subject matter experts.
These evidence and expert consensus-based guidelines are intended to fill any knowledge gaps by sharing the research analysis and best practices directly from the clinicians who have the most experience treating patients with each panel’s specified type of cancer. At the same time, the NCCN Guidelines recommendations are the result of equal input from every member of the panel, regardless of discipline.
In the example provided by Drs. Jatoi and Sah, they point out that the NCCN Guidelines differ from those issued by the Canadian Task Force on Preventive Care and the European Society of Medical Oncology, neither of which has been recently updated with new evidence. The NCCN Guidelines for Prostate Cancer Early Detection is updated at least annually and the current version (v1.2019, published January 31, 2019) addresses both the benefits and harms of screening: In brief, early detection efforts reduce the risk of cancer mortality and its preceding morbidity by at least 30%, but at the cost of possible overdiagnosis of entirely indolent disease that would have caused no symptoms or threat to life if undetected.
In addition, the NCCN Guideline incorporates the U.S. Preventative Task Force’s recent change in its recommendation on the early detection of prostate cancer – issuing a grade “C” recommendation (shared decision to screen) rather than a “D” recommendation (don’t screen).
The NCCN Guidelines are clear on several relevant issues: 1) the decision to undertake screening is a “shared” one as recommended by the USPTF; 2) patients in poor health and of limited life expectancy should not be screened; 3) there are alternatives to immediate biopsy in those with an elevated PSA, thereby limiting unnecessary biopsies; 4) the guidelines are linked to treatment guidelines (NCCN Guidelines for Prostate Cancer), which recommend active surveillance as the appropriate form of treatment for those with low risk disease; and 5) optimal guidelines for those who are African-American and/or those with a known or suspected cancer susceptibility gene, but these groups should be considered for early assessment.
The rationale for considering screening in the general population at age 45, rather than later, is based on: 1) a baseline serum PSA at age 45 is a strong predictor of the future risk of prostate cancer including lethal disease; 2) there is less confounding of PSA assessment by benign prostatic hyperplasia (BPH) at earlier ages; 3) the fact that a small but significant number of men already have high-risk or advanced prostate cancer by their 50s; and 4) screening can be tailored to baseline risk (i.e. much less frequent PSA testing for men with low baseline PSA levels).
The NCCN Guidelines also point out that based on serum PSA levels in men in their 60s, many can stop screening with little future risk. In conclusion, screening for any cancer should by based on the strength and depth of all available evidence.
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