Clinical Guidelines Noncompliance

Editorial: When should primary care practitioners NOT follow clinical practice guidelines?

 

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The Institute of Medicine (IOM) of the National Academy of Sciences defined a clinical practice guideline (CPG) as a “systematically developed statement to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”[1]

The medical literature is replete with observations that primary care practitioners often do not follow clinical practice guidelines. The spectrum of reports includes deviation from recommendations for recognition [2], prevention [3], and treatment [4] of multiple conditions by multiple specialties. Does this mean that primary care practitioners are “bad clinicians”? I think the answer is often quite the contrary, yet I find virtually no published literature analyzing the possible reasons for this phenomenon.

If we dismiss the usual conclusions that we are either uninformed of the guideline recommendations, ignorant of the evidence, or dismissive of the guideline developers, I believe there are circumstances in which a CPG is appropriately set aside. Here are some with examples:

1. Lack of resources either by the practitioner or the patient. For example, a patient had a colonic polyp histologically judged as “low risk” removed 3 years ago and the US Multi-Society Task Force on Colorectal Cancer recommends follow-up colonoscopy this year, however the quality of evidence for that recommendation is labeled as “low” by the guidelines developers. [5] The patient has no health insurance now.  A colonoscopy this year would cost the patient $1000 out of pocket. The patient will be eligible for Medicare in two years. She is informed of the CPG recommendation and elected to wait until she has insurance coverage.

2. Coexisting conditions make the assumptions of the CPG invalid. For example a patient has a mechanical aortic valve, but also Parkinson disease with history of multiple falls. The American College of Chest Physicians guideline recommends warfarin anticoagulation to prevent thrombosis [6], but the probability of further falls with hemorrhage resulting from injury is significant.  He and his doctor decide to use a non-warfarin agent.

3. Individual autonomy in decision-making. For example, many patients refuse insulin therapy for Type 2 diabetes poorly controlled by oral agents despite multiple guidelines that recommend it. [7,8]

4. Community standards or contractual requirements with third parties conflict with the CPG. For example the Society of Anesthesiologists CPG on Pre-anesthesia evaluation describes resting EKG as “a selective test, if indicated”, but most hospitals and surgical centers require it prior to any procedure on every patient. [9]

5. Evidence or expertise cited is not appropriate to primary care practitioners or patients. For example the American Psychiatric Association practice guideline on schizophrenia recommends the use of certain adjunctive medications. [10] Primary care practitioners commonly prescribe most of these medications (e.g. benzodiazepines, antidepressants, and beta-blockers), but most of us do not have enough experience managing the underlying disease to prescribe these medications independently.

6. Multiple CPGs have conflicting recommendations. The United States Prevention Task Force (USPTF) recommends against prostate-specific antigen (PSA) testing in prostate cancer screening [11] whereas the American Cancer Society (ACS) recommends at least an initial PSA test. [12]

Despite the statement that “…guidelines are not fixed protocols that must be followed, but are intended for health care professionals and providers to consider…” buried in fine print at the Agency for Health Research and Quality (AHRQ) web-based resource of CPGs (http://guideline.gov ), both the legal system and the general public assume that deviation from a guideline is malpractice until proven otherwise.  To avoid ignorance of CPGs and their updates, I regularly search the AHRQ National Guideline Clearinghouse resource mentioned above. When I deviate from a CPG in my own practice, I document the reason for doing so. When the deviation is by a patient choice which I believe will expose them to significantly increased risk of adverse outcome, I ask them to sign a statement affirming their choice and its possible consequences and add it to their health record.

The preceding statements represent my own views, and should not be construed as opinion or policy of Primary Care Network.

 

Charles Sneiderman MD PhD DABFP
Family Physician and Medical Director
Culmore Clinic, Falls Church, VA

Published August 16, 2013

Biosketch
Charles Sneiderman, MD PhD, retired in 2010 after a 31-year career in medical informatics at the Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health. His work included research and development in telemedicine, distance learning, and medical language and image processing. Since leaving federal service, he has developed a computerized clinical decision support system to assist primary healthcare practices in the recognition and management of post-traumatic stress syndromes with support from the NLM Disaster Information Management Research Center. Dr. Sneiderman received a B.S. with high honors from the University of Maryland in 1969, and M.D. and Ph.D. degrees from Duke University in 1975 and completed residency training in family medicine at the Medical University of South Carolina in 1979. He has authored numerous scientific reports, book chapters, and medical educational media. Dr. Sneiderman was a Clinical Assistant Professor of Family Practice at the Uniformed Services University of the Health Sciences and maintains certification by the American Board of Family Medicine. He has practiced family medicine part-time in the Washington, DC area since 1980. He has assisted wounded warriors with adaptive snowsports since 2005.

References

1. Field MJ, Lohr KN, eds, Clinical Practice Guidelines: Directions for a New Program. Committee to advise the Public Health Service on Clinical Practice Guidelines. Washington, National Academies Press, 1990. http://www.nap.edu/openbook.php?record_id=1626&page=19

2. O’Connor EA, Whitlock EP, Gaynes B, Beil TL. Screening for Depression in Adults and Older Adults in Primary Care: An Updated Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK36403/

3. Patnode CD, O’Connor E, Whitlock EP, Perdue LA, Soh C, Hollis J. Primary care-relevant interventions for tobacco use prevention and cessation in children and adolescents: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Feb 19;158(4):253-260.

4. Vernacchio L, Vezina RM, Mitchell AA. Management of acute otitis media by primary care physicians: trends since the release of the 2004 American Academy of Pediatrics/American Academy of Family Physicians clinical practice guideline. Pediatrics. 2007;120(2):281–287.

5. Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857.

6. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. Antithrombotic and thrombolytic therapy for valvular disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012 Feb;141(2 Suppl):e576S-600S.

7. Management of Diabetes Mellitus Update Working Group. (2010). VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus. Version 4.0. Washington, DC: Veterans Health Administration and Department of Defense. http://www.healthquality.va.gov/diabetes_mellitus.asp

8. Nathan DM, Buse JB, Davidson MB, et al; American Diabetes Association; European Association for the Study of Diabetes. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009 Jan;52(1):17-30.

9. Committee on Standards and Practice Parameters, Apfelbaum JL, Connis RT, Nickinovich DG; American Society of Anesthesiologists Task Force on Preanesthesia Evaluation, Pasternak LR, Arens JF, Caplan RA, et al. Practice advisory for preanesthesia evaluation: an updated report by the American Society  of Anesthesiologists Task Force on Preanesthesia Evaluation. Anesthesiology. 2012 Mar;116(3):522-538.

10. Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, 2nd edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56.

11. Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17;157(2):120-134.

12. Wolf AM, Wender RC, Etzioni RB, et al; American Cancer Society Prostate Cancer Advisory Committee. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010 Mar-Apr;60(2):70-98.