Glut of Anesthesia Guidelines a Disservice, Except for Lawyers

By Robert E. Johnstone, MD

Anesthesia practice guidelines are out of control—too many to adopt, too anecdotal to accept and too political to take seriously! Every society seems to issue them now, in order to announce their existence, promote their brand or troll for members. I would ignore most of them, but unfortunately lawyers use society guidelines as standards of practice for malpractice suits, to evidence actionable breaches. I might try to follow them, except their scientific bases are weak and they sometimes conflict with each other.

Recently, the Society of Anesthesia and Sleep Medicine published guidelines on treating sleep apnea in Anesthesia and Analgesia.¹ Recommendation 3.1.4 reads, “Patients should continue to wear their Positive Airway Pressure device at appropriate times during their stay in the hospital, both preoperatively and postoperatively.” It sounds reasonable as a way to care for patients with obstructive sleep apnea, except it conflicts with the guidelines of ECRI (Emergency Care Research Institute), the national safety institute, which recommends that “hospitals prohibit the use of patient-owned medical equipment,” citing deaths when they were used.² This is a no-win, catch-22 situation for clinicians.

Who knows what guidelines exist, waiting for plaintiff lawyers and experts to cite? Searching for “best medical practices” through Google yields 300 million items. Narrowing the search to “operating room [OR] guidelines” yields 4.99 million items. Searching for an even more restrictive phrase, “OR standards of practice,” yields 4.36 million items. A zealous anesthesiologist studying one set of practice standards per hour—for eight hours per day, five days per week—would need more than 2,000 years just to read them!

Some societies publish voluminous guidelines. The American Society of Anesthesiologists has 91 standards, guidelines, practice guidelines, practice advisories, statements, positions and definitions—up to 26 pages per document, each with multiple recommendations. Consulting the new ASA guidelines for perioperative blood management, you find, “consider acute normovolemic hemodilution (ANH) to reduce allogeneic blood transfusion in patients at high-risk for excessive bleeding, e.g. major cardiac, orthopedic, thoracic or liver surgery.” Having used ANH—a burdensome effort—I looked up the meta-analysis of the technique, which concludes, “the benefit of ANH is inconsistent and cannot be definitely supported by this overview.”³ It makes you wonder whether the people writing transfusion guidelines have an agenda against blood transfusions.

Conflicts of interest bias experts and pervade guideline-writing groups. A classic article in The New England Journal of Medicine demonstrated a strong association between the published positions of authors on the safety of calcium channel antagonists and their financial relationships with pharmaceutical manufacturers.⁴ A recent New York Times article exposes how the sugar industry paid scientists to blame fat as the food to avoid when they wrote dietary guidelines, leading to the obesity epidemic today.⁵ Charles Denham, MD, a featured ASA speaker, agreed to pay $1 million to settle claims that he accepted kickbacks from CareFusion to promote ChloraPrep in clinical guidelines.⁶ In fact, so many studies have documented the influence of industry support on guidelines that nowadays any guideline that promotes an anesthetic drug or equipment seems suspect.

In addition to ideology and money, politics influences guidelines. The American Association of Nurse Anesthetists has dozens of practice documents that promote independent practice. Their chronic pain management guideline states, “CRNAs [certified registered nurse anesthetists] are uniquely skilled to deliver pain treatment. … These techniques may include, but are not limited to … intrathecal injection, epidural steroid injection, nerve ablation techniques, and … implantable systems.” This seems more a polemic against anesthesiologists than guidance for nurse anesthetists, a statement to undermine anesthesiologists’ breadth of education and medical direction of a care team.

Societies clash over their conflicting guidelines, as they issue these member-attractive promotions. The Association of periOperative Registered Nurses (AORN), for instance, published a guideline empowering nurses to control what surgeons and anesthesiologists wear in ORs. The guideline embellished information from the CDC that reported on two patient infections. When society-empowered nurses tried to enforce this anecdotally supported guideline and make surgeons wear bouffant head coverings, surgeons protested and the American College of Surgeons published the statement, “The skull cap may be worn when close to the totality of hair is covered by it.” AORN sought ASA support in managing surgeons, but the ASA refused due to the lack of evidence behind the dubious guideline. The nursing association, however, recruits members with the tagline, “AORN supports the nurses who keep surgery safe,” so it doubled down with a guideline implementation book, containing a bewhiskered surgeon cartoon captioned, “What’s wrong with this picture?”

These society promotions and guideline brouhahas would be great fun except that accreditors, regulators and lawyers cite and use them. Daniel Shuman, in a defining legal article, equated society guidelines with standards of practice.⁷ He wrote, “Health care professionals should be held accountable when they deviate from relevant empirically grounded professional standards without good cause.” In Washington v. Washington Hospital Center, a court of appeals upheld that not following the ASA guidelines exactly was sufficient grounds for a jury to find an anesthesiologist negligent. The American Medical Association is studying programs of tort reform that use clinical practice guidelines to screen cases for assessing liability. Tom Price, secretary of the Department of Health and Human Services, has called for establishing clinical practice guidelines that physicians could use to defend themselves against malpractice claims.⁸

Reformers and educators are piling on. The movement toward value-based reimbursement means paying clinicians for following guidelines. The American Board of Anesthesiology’s “Maintenance of Certification in Anesthesiology” program encourages clinicians to design their own guidelines, the ultimate in narrowness.

We need to cut the glut. Narrowly focused societies and committees should stop promoting themselves by issuing guidelines, and anesthesiologists should stop accepting them. I have appreciated broad-based ASA standards that improve patient safety, but too many opinion-derived, narrowly focused practice statements are grouped with these standards. The ASA states, “Consensus-based practice parameters are developed by ASA-appointed experts who formulate opinions using a variety of methods and resources. When available, scientific evidence may be considered.” This is too weak to publish as practice guidelines.

Clinicians are already ignoring and pushing back on guidelines. A study presented at the recent ASA annual meeting examined whether hospitals in Michigan adhere to ASA NPO (nothing by mouth) guidelines, and found the majority do not.⁹ A panel discussion at the recent PostGraduate Assembly in Anesthesiology, titled “The Weaponization of Medical Quality Improvement,” mocked biased and flawed practice protocols enforced by regulators and institutions. At best, guidelines standardize treatments and improve outcomes; at worst, they promote industry products, stifle innovation, enrich lawyers and create an illusion of quality.

We should stop pretending all guidelines are sacrosanct, even those of the ASA, and winnow them to the few that are. Cutting the bad ones will elevate the good ones. Societies that continue to spew weak and conflicted guidelines should be called out, even mocked.

References

1. Chung F, et al. Society of anesthesia and sleep medicine guidelines on preoperative screening and assessment of adult patients with obstructive sleep apnea. Anesth Analg. 2016;123:452-473.
2. Hazard report. Using patient-supplied respiratory care equipment in hospitals requires careful assessment. Health Devices. 2009;38:417-418.
3. Bryson GL, et al. Does acute normovolemic hemodilution reduce perioperative allogeneic transfusion? A meta-analysis. The International Study of Perioperative Transfusion. Anesth Analg. 1998;86:9-15.
4. Stelfox HT, et al. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med. 1998;338:101-106.
5. Domonske C. 50 years ago, sugar industry quietly paid scientists to point blame at fat. New York Times. September 13, 2016.
6. S. Department of Justice. United States settles False Claims Act allegations against patient safety consultant and his companies. www.justice.gov/?opa/?pr/?united-states-settles-false-claims-act-allegations-against-patient-safety-consultant-and-his. March 2, 2015. Accessed January 9, 2017.
7. Shuman DW. The standard of care in medical malpractice claims, clinical practice guidelines, and managed care: towards a therapeutic harmony? California West Law Rev. 1997;34:99-114.
8. Terhune C. Top Republicans say there’s a medical malpractice crisis. Experts say there isn’t. Kaiser Health News. December 30, 2016.
9. Thampy MS, et al. To eat or not to eat. Examining adherence to ASA NPO guidelines in Michigan Presented at: 2016 annual meeting of the American Society of Anesthesiologists; October 22-26, 2016; Chicago, IL. Abstract A1024.