Pg 1
Controversies in Guidelines:
Where is the evidence that they actually improve outcomes?
Martin J. London, M.D.
Professor of Clinical Anesthesia
University of California, San Francisco
SCA Annual Meeting 2014
Clinical Guidelines have become a major industry in the brave new world of
“evidence-based medicine”. Many major subspecialty medical societies and health
related governmental agencies (eg. NHLBI) have spent many millions of dollars over the
past several decades since the very first one was published by the American College of
Cardiology/American Heart Association (on pacemakers) in 1984. 1 Most SCA members
are likely to be fairly well acquainted with a few relevant guidelines produced by the
ACC/AHA of direct interest to our practices, as well as to management of patients with
many forms of CV disease (IHD, CHF, Valvular, HOCM, etc.) that we encounter. 2 As
well those produced by ASA in collaboration with the SCA have dealt with key process
issues such as PA catheterization, TEE, and most recently Central Venous Access (which
caused some degree of controversy in the ASA House of Delegates related to
recommended use of surface ultrasound). 3-5 Given the echo focus of the SCA, we have
been well represented on a number of guidelines from the American Society of
Echocardiography (most notably of course the TEE based ones, but also
epicardial/epiaortic imaging and vascular cannulation). As well, SCA has partnered on
several occasions with the Society of Thoracic Surgeons, most notably on blood
conservation guidelines for cardiac surgery. 6 CV practitioners who also wear a critical
care hat at times are likely to be familiar with those from the Society of Critical Care
Medicine (on management of sepsis), the American College of Chest Physicians (on
management of thrombosis and also atrial fibrillation), those related to postoperative
management of cardiac patients (including secondary prevention strategies after CABG
popularized by the AHA’s “Get with the Guidelines” program) and the recent
ACC/AHA/STS/SCA CABG guidelines and more recently by the AABB’s Guidelines on
Blood Transfusion. 7,8
Pg 2
The current status of the universe of guidelines can probably best appreciated by a
quick trip to the well maintained section of Agency for Healthcare Research and
Quality’s website where a large list of guidelines indexed by the responsible society is
warehoused (http://www.guideline.gov). This “guideline clearinghouse” is a great effort
to develop new strategies to deal with the proliferation of guidelines that are often
produced in a somewhat haphazard manner by “up and coming” societies with a variety
of intentions (primarily good willed but possibly also to make themselves more visible). 9
Although there has been “rumbling” among various “end users” of guidelines,
almost from the start of the process several decades ago by front line physicians to
academic physicians and health researchers trying to figure out who is doing what and
how. 10-13 The prestigious Institute of Medicine has gotten involved in this process in a
major way developing “Clinical Practice Guidelines We Can Trust” (Standards March
2011, www.iom.edu) with a very broad focus including controversial recommendations
to include the lay public on guideline panels. Recently, the often public squabbles
between various factions of the same subspecialty society have spilled over big time into
the public media. Two recent and particularly heated topics have been reported very
frequently (and to my opinion quite expertly) in the New York Times as well as most of
the known “blogosphere”. The firestorm of criticism over the recent ACC/AHA
Guidelines for Cholesterol Management with its focus exclusively on randomized trials
and dependence of very controversial cardiac risk calculators made it eminently clear to
the public that guidelines are “etched in stone”. 14 The very long drawn out and
contentious process involved in updating the new JNC 8 guidelines for management of
hypertension (perhaps the most important public health issue in the country), involving
fumbles and “blown calls” between the government (NHLBI) and organizations such as
ACC/AHA have also emphasized problems with this process. 15 Finally, not an issue that
has made the news, but one that many CV anesthesiologists are interested in, is the
somewhat embarrassing situation that the European Society of Cardiology has found
itself in with Don Poldermans, the lead author of their Perioperative Evaluation
Guidelines, who has been sacked by his prior employers (Erasmus University,
Netherlands) for suspicion of academic impropriety and despite protesting his innocence,
has clearly become a persona non gratis in academia. 16 That organization posted a note
Pg 3
that it would review the status of the guidelines but has not taken any official action that I
am aware of as of yet (and none of his articles have been retracted from any journals as
well despite a strongly worded “letter of concern” by the Journal of the American College
of Cardiology). Thus, guideline controversies come in all shapes and flavors!
In this short lecture, I will attempt to highlight a few of the less spectacular
guidelines that most of us deal with in SCA (as noted above), highlighting what may or
may not be known (or scientifically studied) regarding the evidence that guidelines
actually alter outcome. I will also point out some of the potential major differences in
methodology that even these few organizations use and speculate whether or not there
ever will be real standardization! There are limited data out there on a few issues of
interest such as how well various practitioners are of some guidelines (particularly the
AHA Perioperative Evaluation Stress Testing and Beta Blocker Recommendations and
the STS/SCA Blood Management guidelines). 17-30 Having been involved in the CABG
guideline I will also point out what I just recently realized is an obvious flaw in the
guideline dissemination process via the a lack of thorough guideline indexing for various
process related subcomponents covered in the guideline (there are only five mesh terms
for the entire guideline!) as well as how lack of publicity by Executive leadership perhaps
has kept some of the issues addressed with formal recommendations permanently “off the
radar”.
I think as most of us would guess that trying to scientifically prove the efficacy of
a process which is so “prolific” and so well ingrained into our often flawed individual,
group and national decision health policy making is nearly impossible. Obviously, there
is no way to do a simultaneous randomized trial of a guideline versus its “non-use” so
any designs are inherently flawed anyway. My personal opinion is that guidelines are an
absolutely necessary and incredibly valuable service provided to rank and file physicians
and other health care providers. Inevitable advances in handling of “big data” and
“bibliometry” (eg. automated data searching of literature citations in databases such as
PUBMED) allowing capture of information from a burgeoning number of journals and
even major data registries and much more precise grading and synthesis of such data will
take much of the controversy out of guidelines in the next decade. They will not only
Pg 4
alter outcomes, but also drive our practice patterns unless other compelling information
emerges.
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Frye RL, Collins JJ, DeSanctis RW, et al.: Guidelines for permanent cardiac
pacemaker implantation, May 1984. A report of the Joint American College of
Cardiology/American Heart Association Task Force on Assessment of
Cardiovascular Procedures (Subcommittee on Pacemaker Implantation). Circulation
1984; 70: 331A-339A
London MJ: The role of the SCA and the cardiovascular anesthesiologist in
guideline development: The 2011 AHA/ACCF CABG guidelines as a case in point,
Practice Guidelines in Cardiovascular Anesthesia: Updates and Controversies.
Edited by London MJ. Baltimore, Lippincott Williams & Wilkins, 2012, pp 17 - 33
American SoAaSoCATFoTE: Practice guidelines for perioperative transesophageal
echocardiography. An updated report by the American Society of Anesthesiologists
and the Society of Cardiovascular Anesthesiologists Task Force on Transesophageal
Echocardiography. Anesthesiology 2010; 112: 1084-96
Anonymous: Practice guidelines for pulmonary artery catheterization: an updated
report by the American Society of Anesthesiologists Task Force on Pulmonary
Artery Catheterization. Anesthesiology 2003; 99: 988-1014
Rupp SM, Apfelbaum JL, Blitt C, et al.: Practice guidelines for central venous
access: a report by the American Society of Anesthesiologists Task Force on Central
Venous Access. Anesthesiology 2012; 116: 539-73
Ferraris VA, Brown JR, Despotis GJ, et al.: 2011 update to the Society of Thoracic
Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation
clinical practice guidelines. Ann Thorac Surg 2011; 91: 944-82
Denton TA, Fonarow GC, LaBresh KA, Trento A: Secondary prevention after
coronary bypass: the American Heart Association "Get with the Guidelines"
program. Ann Thorac Surg 2003; 75: 758-60.
Carson JL, Grossman BJ, Kleinman S, et al.: Red Blood Cell Transfusion: A Clinical
Practice Guideline From the AABB*. Ann Intern Med 2012; 157: 49-58
Kahn R, Gale EA: Gridlocked guidelines for diabetes. Lancet 2010; 375: 2203-4
Cabana MD, Rand CS, Powe NR, et al.: Why don't physicians follow clinical
practice guidelines? A framework for improvement. Jama 1999; 282: 1458-65
Shaneyfelt TM, Mayo-Smith MF, Rothwangl J: Are guidelines following guidelines?
The methodological quality of clinical practice guidelines in the peer-reviewed
medical literature. JAMA 1999; 281: 1900-5
Grilli R, Magrini N, Penna A, et al.: Practice guidelines developed by specialty
societies: the need for a critical appraisal. Lancet 2000; 355: 103-6
Choudhry NK, Stelfox HT, Detsky AS: Relationships between authors of clinical
practice guidelines and the pharmaceutical industry. JAMA 2002; 287: 612-7
Stone NJ, Robinson J, Lichtenstein AH, et al.: 2013 ACC/AHA Guideline on the
Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in
Pg 5
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
Adults: A Report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines. Circulation 2013
James PA, Oparil S, Carter BL, et al.: 2014 Evidence-Based Guideline for the
Management of High Blood Pressure in Adults: Report From the Panel Members
Appointed to the Eighth Joint National Committee (JNC 8). JAMA 2013
Poldermans D, Bax JJ, Boersma E, et al.: Guidelines for pre-operative cardiac risk
assessment and perioperative cardiac management in non-cardiac surgery. Eur Heart
J 2009; 30: 2769-812
Stover EP, Siegel LC, Parks R, et al.: Variability in transfusion practice for coronary
artery bypass surgery persists despite national consensus guidelines: a 24-institution
study. Institutions of the Multicenter Study of Perioperative Ischemia Research
Group. Anesthesiology 1998; 88: 327-33
Fyfe D: Transesophageal echocardiography guidelines: return to bypass or to bypass
the guidelines? J Am Soc Echocardiogr 1999; 12: 343-4
Farid I, Litaker D, Tetzlaff JE: Implementing ACC/AHA guidelines for the
preoperative management of patients with coronary artery disease scheduled for
noncardiac surgery: effect on perioperative outcome. J Clin Anesth 2002; 14: 126-8
Cassar K, Belch JJ, Brittenden J: Are national cardiac guidelines being applied by
vascular surgeons? Eur J Vasc Endovasc Surg 2003; 26: 623-8
Falcone RA, Nass C, Jermyn R, et al.: The value of preoperative pharmacologic
stress testing before vascular surgery using ACC/AHA guidelines: a prospective,
randomized trial. J Cardiothorac Vasc Anesth 2003; 17: 694-8
Gordon AJ, Macpherson DS: Guideline chaos: conflicting recommendations for
preoperative cardiac assessment. Am J Cardiol 2003; 91: 1299-303
Siddiqui AK, Ahmed S, Delbeau H, et al.: Lack of physician concordance with
guidelines on the perioperative use of beta-blockers. Arch Intern Med 2004; 164:
664-7
Almanaseer Y, Mukherjee D, Kline-Rogers EM, et al.: Implementation of the
ACC/AHA guidelines for preoperative cardiac risk assessment in a general medicine
preoperative clinic: improving efficiency and preserving outcomes. Cardiology
2005; 103: 24-9
Barak M, Ben-Abraham R, Katz Y: ACC/AHA guidelines for preoperative
cardiovascular evaluation for noncardiac surgery: a critical point of view. Clin
Cardiol 2006; 29: 195-8
Likosky DS, FitzGerald DC, Groom RC, et al.: The effect of the perioperative blood
transfusion and blood conservation in cardiac surgery Clinical Practice Guidelines of
the Society of Thoracic Surgeons and the Society of Cardiovascular
Anesthesiologists upon clinical practices. J Extra Corpor Technol 2010; 42: 114-21
Likosky DS, FitzGerald DC, Groom RC, et al.: Effect of the perioperative blood
transfusion and blood conservation in cardiac surgery clinical practice guidelines of
the Society of Thoracic Surgeons and the Society of Cardiovascular
Anesthesiologists upon clinical practices. Anesth Analg 2010; 111: 316-23
London MJ: New practice guidelines for perioperative beta blockade from the
United States and Europe: incremental progress or a necessary evil? Can J Anaesth
2010; 57: 301-12
Pg 6
29. Sear JW, Foex P: Recommendations on perioperative beta-blockers: differing
guidelines: so what should the clinician do? Br J Anaesth 2010; 104: 273-5
30. Vigoda MM, Sweitzer B, Miljkovic N, et al.: 2007 American College of
Cardiology/American Heart Association (ACC/AHA) Guidelines on perioperative
cardiac evaluation are usually incorrectly applied by anesthesiology residents
evaluating simulated patients. Anesth Analg 2011; 112: 940-9