What's Wrong with Expert Opinion?

In this month's Pulmonary Journal Club Dr. Mathew reviews an article by Feuerstein et al. (1) from Beth Israel Deaconess Medical Center and Harvard Medical School published in the Mayo Clinic Proceedings (2). The authors reviewed  the evidence basis for 153 interventional guidelines including 2 from the American College of Chest Physicians and the American Thoracic Society. Of the 3425 recommendations reviewed, 11% were supported by level A evidence, 42% by level B, and 48% by level C. These numbers are very close to the results published by Lee and Vielemeyer (3) for the Infectious Disease Society of America guidelines where only 14% of the guidelines were based on level A evidence and 55% by level C.

So what's wrong with the majority of guidelines based on expert opinion? After all, these are experts in the field and it can be argued that most of these opinions are probably right and that physicians want guidance from the experts. The problem is that they are opinion and sometimes wrong. When they are wrong the potential exists for causing large and devastating harm to patients. This has become an increasingly frequent. As examples:

1. Tight control of glucose in the intensive care unit which according to the largest and best done multi-center trial, causes a 14% increase in ICU mortality (4).
2. Xigris (activated protein C) for adults with septic shock which caused an increase in bleeding and a small but insignificant increase in mortality leading to withdrawal of the drug (5).
3. Perioperative beta blockers which Cole and Francis calculated caused an excess mortality of 800,000 deaths in Europe over the past 5 years (6).
4. Fluid boluses for in African children with severe infection which caused a 49% increase in mortality (7).

Guideline interventions leading to a decrease in mortality are rare and there are no carefully-done, randomized trials of guidelines that have shown a 14% decrease in mortality in the ICU, saved 800,000 lives or improved mortality by 49% in severe infection. So the question arises why were these guidelines put in place, and in some cases, why do they persist? In an editorial which was to be published on January 21 in the European Heart Journal, Cole and Francis raised the possibility that the responsibility for misconduct lies not just with misguided researchers but also the institutions and the institutional leaders that provide uncritical support to research factories. Further, they discussed the role of journal editors and, even, journal readers. However, the two editorials were withdrawn about an hour after the first was published.

It appears that some guidelines have become a cesspool of conflicts of interest (COI). As pointed out in the article Dr. Mathew reviewed, 62% of the guidelines failed to comment on COIs; when disclosed, 91% of guidelines reported COIs. In a egregious example of COI influencing guidelines, the research done by Don Poldermans on perioperative beta blockers has been discredited and he has been dismissed from his university (6). Poldermans also chaired the guideline writing committee for the European Society of Cardiology on perioperative beta blockers. The previously mentioned editorials by Cole and Francis discussing Poldermans' research and its implications were retracted by the European Heart Journal. Why the journal chose to retract the editorials is unclear but one wonders if threats of loss of advertising or lawsuits from pharmaceutical company lawyers may have had something to do with it.

The story of Xigris is a further example of COIs gone amuck (8,9). Eli Lilly, the manufacturer of Xigris, provided a $1.8 million grant to fund a task force on “Values, Ethics and Rationing in Critical Care” reportedly to further the concept that it was unethical to withhold Xigris from septic patients. Eli Lilly provided over 90% of the funding for The Surviving Sepsis Campaign, launched in October 2002 to create guidelines for the treatment of sepsis.  Many of the international experts who formulated the recommendations of this group had significant outside financial relationships with Eli Lilly. As subsequent prospective trials began to raise important concerns regarding the safety and efficacy of Xigris, these concerns were repeatedly and conspicuously absent from published recommendations of the Surviving Sepsis campaign. In 2004, Eli Lilly started a program of offering unrestricted grants to institutions for implementing Surviving Sepsis Campaign patient management bundles.

The leaders in healthcare from the Institute of Healthcare Improvement (IHI) to the local leaders often have substantial COIs combined with a weak backgrounds in medicine and research. For example, the evidence basis for IHI's 100,000 Lives Campaign was weak (10). However, the non-peer reviewed press releases allowed IHI to receive a landslide of “brand recognition” which undoubtedly led to substantial new revenues and philanthropic dollars (10). Locally, many CEOs and managers are operating under incentive systems that tie bonuses to guideline compliance. One chairman of medicine, asked me, "Why is my bonus tied to how many pneumococcal vaccines are administered?". Others may not be so willing to question the hand that feeds them.

It is unclear why professional societies and medical boards have been so silent about guidelines with a weak evidence base. Both were created to protect the public's health. Practice of medicine and nursing has been restricted to those with appropriate education and licensure who accept the responsibility for their actions. The guideline process can allow the unscrupulous to side step these regulations and responsibility, sometimes for their own financial gain. If the medical societies and medical boards are unwilling to intervene, perhaps a federal agency or regulator not vulnerable to such concerns might be better suited to regulate the implementation of guidelines.

Richard A. Robbins, MD*

Editor

References

1. Feuerstein JD, Akbari M, Gifford AE, Hurley CM, Leffler DA, Sheth SG, Cheifetz AS. Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines. Mayo Clin Proc. 2014;89(1):16-24. [CrossRef] [PubMed] 
2. Mathew M. January 2014 pulmonary journal club: interventional guidelines. Southwest J Pulm Crit Care. 2014;8(1):70. [CrossRef]
3. Lee DH, Vielemeyer O. Analysis of overall level of evidence behind infectious diseases society of America practice guidelines. Arch Intern Med. 2011;171:18-22. [CrossRef] [PubMed] 
4. NICE-SUGAR Study Investigators, Finfer S, Chittock DR, et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360(13):1283-97. [CrossRef] [PubMed] 
5. Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 2012; 366:2055-64. [CrossRef] [PubMed] 
6. Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011;364(26):2483-95. [CrossRef] [PubMed] 
7. Eichacker PQ, Natanson C, Danner RL. Surviving Sepsis – Practice guidelines, marketing campaigns and Eli Lilly. N Engl J Med 2006;355:1640-2. [CrossRef] [PubMed]
8. Raschke RA. July 2012 critical care journal club. Southwest J Pulm Crit Care 2012;5:54-7.
9. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]

*The views expressed in this editorial are those of the author and do not necessarily represent the views of the Arizona, New Mexico, Colorado or California Thoracic Societies or the Mayo Clinic.

Reference as: Robbins RA. What's wrong with expert opinion? Southwest J Pulm Crit Care. 2014;8(1):71-3. doi: http://dx.doi.org/10.13175/swjpcc008-14 PDF

Choosing Wisely-Where Is the Choice?

A little over a year ago an editorial was posted in the Southwest Journal about the Choosing Wisely campaign from the American Board of Internal Medicine and Consumer Reports (1). You may remember that Choosing Wisely announced a list of procedures or treatments that patients should question (2). In the editorial we wondered why pulmonary organizations such as the American Thoracic Society (ATS) and the American College of Chest Physicians authored none of the recommendations and offered 10 suggestions. We also openly questioned if the recommendations were intended to improve patient care or reduce costs, and thus improve the profits of third party carriers.

We can now report that recommendations were announced at the recent ATS meeting in Philadelphia. Seven recommendations were made for critical care and seven for pulmonary disease. Five from the critical care list and five from the pulmonary list will eventually be chosen for inclusion in Choosing Wisely. The recommendations are listed below:

Critical Care

1. Thou shalt not order diagnostic tests at regular intervals (e.g., daily) but instead order tests based on needs.
2. Thou shalt not use parenteral nutrition in the first 7 days of an ICU admission in patients adequately nourished.
3. Thou shalt not transfuse red blood cells in hemodynamically stable patients with a hemoglobin > 7 gm/dL.
4. Thou shalt not sedate mechanically ventilated patients without an indication.
5. Thou shalt not continue life support for at patients at high risk for death.
6. Thou shalt not initiate or continue antimicrobials without an indication.
7. Thou shalt not place or maintain an arterial or central venous catheter without an indication.

Pulmonary

1. Thou shall not perform thoracic CT scans for follow up of pulmonary nodules more frequently than the guidelines (Fleishner Society) suggest.
2. Thou shalt not discontinue oxygen from recently discharged patient prescribed oxygen without checking for hypoxemia.
3. Thou shalt not routinely administer intravenous corticosteroids for exacerbations of asthma or chronic obstructive pulmonary disease when the patient is able to take oral steroids.
4. Thou shalt not do thoracic CT scan screening for patients at low risk for lung cancer.
5. Thou shalt not do chest x-rays on asymptomatic patients routinely.
6. Thou shalt not offer vasoactive agents for groups 2 (left heart disease) and 3 (hypoxia) pulmonary artery hypertension (PAH).
7. Thou shalt not perform thoracic CT angiography for pulmonary embolism on patients with low probability and a negative d-dimer.

In the question and answer session after the recommendations were presented, a member of the audience noted that most of the recommendations were negative, directing physicians what not to do. We confess that we added the “Thou shalt not …” to emphasize this point but cannot overlook the fact that these recommendations look suspiciously like commandments. The negativity implicit in the ATS recommendations is consistent with the recommendations by other subspecialties listed on the Choosing Wisely website (2).  While the recommendations are reputedly about reducing the use of unnecessary or potentially dangerous testing, both worthy goals, the tone suggests there will be consequences for failure to comply.

What we find offensive is the Choosing Wisely and ultimately the ABIM foundation assertion that this is an initiative “focused on encouraging physicians, patients and other health care stakeholders to think and talk about medical tests and procedures that may be unnecessary” (2). Where is the encouragement and where is the choice in a series of DO NOT commandments?  It seems an even-handed approach of an objective statement would be much more appropriate and yet carry the same information, e.g. Chest CT scans are rarely required for screening patients at low risk for lung cancer rather than “Do not do thoracic CT scan screening for patients at low risk for lung cancer”.  It seems that rather than encouraging conversation the Choosing Wisely statement puts doctor and patient in an adversarial relationship especially if the doctor feels something is needed which is expressly stated with a “Do not”.

Rather than a laundry list of no-no’s a guiding principle might be better. The American College of Physicians (ACP) has offered, “The physician should always act in the best interests of the patient” (3). Despite objections to the profession of the author of the ACP statement, a lawyer, the overall sentiment is a good one (4). It removes the adversarial relationship the Choosing Wisely campaign encourages and places physicians where they belong-on the side of the patient.

In our view the present Choosing Wisely campaign has fundamental flaws-not because it is medically wrong but because it attempts to replace choice and good judgment with a rigid set of rules that undoubtedly will have many exceptions. Based on what we have seen so far, we suspect that Choosing Wisely is much more about saving money than improving patient care. We also predict it will be used by the unknowing or unscrupulous to further interfere with the doctor-patient relationship.  When the recommendations of an authoritarian body take the form of commandments and preempt clinical decision making, then it seems the wise choice of a wary clinician is to tacitly comply - in other words there is no choice.

Richard A. Robbins, M.D.*

Allen R. Thomas, M.D.*

References

1. Robbins RA, Thomas AR. Will fewer tests improve healthcare or profits? Southwest J Pulm Crit Care 2012;4:111-3.
2. http://www.choosingwisely.org/ (accessed 6/3/13).
3. Snyder L.  American College of Physicians Ethics Manual.  Sixth Edition.  Ann Intern Med. 2012:156;1:suppl 73-101.
4. Raschke RA. February 2012 critical care journal club. Southwest J Pulm Crit Care 2012;4:51-2.

*The opinions expressed in this editorial are the opinions of the authors and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona, New Mexico or Colorado Thoracic Societies.

Reference as: Robbins RA, Thomas AR. Choosing wisely-where is the choice? Southwest J Pulm Crit Care. 2013;6(6):272-4. PDF