Editorials
See related "Practice Guidelines" on page 2713.
A Joint Clinical Practice Guideline for Acute Otitis Media
theodore g.
ganiats, m.d.
University of California
San Diego, California
allan s.
lieberthal, m.d.
Kaiser-Permanente Center
Panorama City,
California
larry culpepper,
m.d., m.p.h.
Boston University School of Medicine
Boston,
Massachusetts
martin c.
mahoney, m.d., ph.d.
State University of New York at Buffalo
Buffalo, New York
For the AAP/AAFP Subcommittee on Acute Otitis Media
An evidence-based clinical practice guideline1 to inform physicians on the
management of uncomplicated acute otitis media (AOM) among children ages two
months through
12 years is now available. It was developed by the
multidisciplinary Subcommittee on Management of Acute Otitis Media, which was
composed of representatives from the American Academy of Pediatrics (AAP), the
American Academy of Family Physicians (AAFP), and other relevant professional
organizations. A summary of this clinical practice guideline appears in this
issue of American Family
Physician.2
Using a methodology similar to that used for the recent guideline on the management of otitis media with effusion,3 this AOM guideline is based on the best available published data as summarized in the Agency for Healthcare Research and Quality report on AOM4 and literature subsequently published through September 2003. Evidence-based statements contained in the AOM guideline1 follow AAP definitions, reflecting both the quality of evidence and the balance of benefit and harm.5
To highlight the key points, the guideline1 offers recommendations for accurate diagnosis, assessment, and treatment of pain, and the use of an observation option among selected patients, with interval reassessment.
• The diagnosis of AOM requires that the clinician confirm a history of acute onset, identify signs of middle ear effusion, and evaluate for the presence of signs and symptoms of middle ear inflammation. [Recommendation] The degree of diagnostic certainty, which should be discussed with the child's caregiver, is important because of its impact on management strategies.
• The management of AOM should include an assessment of pain. If pain is present, the clinician should recommend treatment to reduce pain. [Strong recommendation] Be-cause episodes of AOM commonly are associated with varying levels of discomfort, management of pain should be addressed.
• Observation without the use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic certainty, age, illness severity, and assurance of follow-up. [Option] This "observation option" should be limited to otherwise healthy children six months to two years of age with nonsevere illness at presentation and an uncertain diagnosis, and to children two years of age and older without severe symptoms at presentation or with an uncertain diagnosis; access to follow-up care also should be ensured.
This observation option relies on clinical judgment and provides an opportunity for the patient to improve without antibacterial treatment. Most cases of AOM resolve, with 61 percent of children having decreased symptoms after 24 hours whether they receive placebo or antibacterial agents; by seven days, about 75 percent of children have resolution of symptoms.6 A meta-analysis4 showed that there was a 12 percent reduction in the clinical failure rate within two to seven days of diagnosis when ampicillin or amoxicillin was prescribed, compared with an initial use of placebo or observation (number needed to treat, 8).
In 1990, observation was successfully implemented in the Netherlands and has been jointly promoted since 2002 by the New York State Department of Health and the New York Region Otitis Project Committee.7,8
• If a decision is made to treat with an antibacterial agent, the clinician should prescribe amoxicillin for most children. [Recommendation] The justification to use amoxicillin as first-line therapy in most patients with AOM relates to its general effectiveness when used in sufficient dosages (80 to 90 mg per kg per day). The optimal duration of therapy is uncertain, and clinical judgment is advised.
• Patients who fail to respond to the initial management option within 48 to 72 hours warrant reassessment to confirm AOM and exclude other causes of illness. If AOM is confirmed in the patient initially managed with observation, the clinician should begin antibacterial therapy. If the patient initially was managed with an antibacterial agent(s), the clinician should change the antibacterial agent(s). [Recommendation]
• Clinicians should encourage the prevention of AOM through reduction of risk factors. [Recommendation] Risk factor reduction includes promoting the use of pneumococcal conjugate and influenza vaccines.
The guideline made no recommendation regarding the use of complementary and alternative medicine in the management of AOM because of the lack of evidence documenting efficacy. In addition, the guideline identifies multiple research issues for primary care researchers relating to the diagnosis and management of AOM.
Care providers represent an important ally to engage regarding monitoring and follow-up of children managed with the observation option. It should be noted, however, that these guidelines are not appropriate for all practice settings, and some may view these guidelines as controversial. These joint AOM guidelines provide valuable support for efforts to integrate evidence into clinical practice while potentially decreasing the unnecessary use of antibiotics.
The complete AOM guideline, along with a set of questions and answers related to the guideline, can be found at the AAFP Web site at http://www.aafp.org/x26481.xml.
Theodore G. Ganiats, m.d., is executive director of the University of California-San Diego Health Outcomes Assessment Program, San Diego. Dr. Ganiats served as the American Academy of Family Physicians (AAFP) Co-Chair on the American Academy of Pediatrics (AAP)/AAFP Subcommittee for Acute Otitis Media.
Allan S. Lieberthal, m.d., is a pediatrician at the Kaiser-Permanente Center, Panorama City, Calif., and clinical professor of pediatrics at the University of Southern California-Keck School of Medicine, Los Angeles. Dr. Lieberthal served as the AAP Co-Chair on the AAP/AAFP Subcommittee for Acute Otitis Media.
Larry Culpepper, m.d., m.p.h., is professor and chairman of the Department of Family Medicine at the Boston University School of Medicine, Boston. Dr. Culpepper served on the AAP/AAFP Subcommittee for Acute Otitis Media.
Martin C. Mahoney, m.d., Ph.D., is associate professor in the Department of Family Medicine at the School of Medicine & Biomedical Sciences, State University of New York, Buffalo. Dr. Mahoney served on the AAP/AAFP Subcommittee for Acute Otitis Media.
Address correspondence to Martin C. Mahoney, M.D., Ph.D., Department of Family Medicine, 462 Grider Street, Buffalo, NY 14215 (e-mail: mmahone@acsu.buffalo.edu). Reprints are not available from the authors.
REFERENCES
1. Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics 2004;113:1451-65.
2. AAP, AAFP release guideline on diagnosis and management of acute otitis media [prac guide]. Am Fam Physician 2004;69:2713-5.
3. Subcommittee on Otitis Media With Effusion. Otitis media with effusion. Pediatrics 2004;113:1412-29.
4. Marcy M, Takata G, Agency for Healthcare Re-search and Quality. Management of acute otitis media. Evidence report/technology assessment No. 15, AHRQ Publication No. 01-E010. Rockville, Md.: Agency for Healthcare Research and Quality, 2001.
5. American Academy of Pediatrics. Steering Committee on Quality Improvement and Management. Classifying recommendations for clinical practice guidelines. Pediatrics. [In press.]
6. Rosenfeld RM, Bluestone CD, eds. Evidence-based otitis media. 2d ed. Hamilton, Ontario: Decker, 2003.
7. Rosenfeld RM. Observation option toolkit for acute otitis media. Int J Pediatr Otorhinolaryngol 2001; 58:1-8.
8. New York Regional Otitis Project. Observation option toolkit for acute otitis media. Albany, N.Y.: State of New York, Department of Health, Publication No. 4894, 2002.
The Persistent Value of the Autopsy
KAVEH G. SHOJANIA, M.D.
University of
California
San Francisco, California
ELIZABETH C. BURTON, M.D.
Baylor Health Care
System
Dallas, Texas
An extensive literature documents substantial rates of missed diagnoses that are detected at autopsy, including diagnoses that likely affected outcome.1-4 Physicians generally have attributed these findings to selection bias. With the national autopsy rate for nonforensic deaths having fallen to roughly 5 percent,5 physicians may request autopsy precisely in those cases likely to reveal important new diagnoses.
In response to a request by the College of American Pathologists and funded by the Agency for Healthcare Research and Quality, we systematically reviewed the literature to assess time trends in autopsy-detected diagnostic errors and to specifically address the question of whether clinical selection bias explains the persistent error rates that are reported even in contemporary autopsy series.6
We reviewed more than 200 studies of autopsy-detected errors in clinical diagnosis,6 53 of which met prespecified inclusion criteria.1,2 Discrepancies between clinical and autopsy diagnoses were defined as "major errors" when a clinically missed diagnosis involved a principal underlying disease or primary cause of death; and they were defined as "class I errors" when the patient might have survived to hospital discharge if antemortem diagnosis had occurred.
The 53 studies included some that spanned a 40-year period (1959 to 1999) and reported major and class I error rates of 23.5 percent (range, 4.1 to 49.8 percent) and 9.0 percent (range, zero to 20.7 percent), respectively.
Despite steady declines in major and class I error rates, typical U.S. institutions in the year 2000 observed a major error rate ranging from 8.4 to 24.4 percent, based on autopsy rates ranging from 100 percent (the extrapolated extreme at which clinical selection is eliminated) to 5 percent (roughly the national average). The same range of autopsy rates would produce class I error rates of 4.1 to 6.7 percent.7
Although we used the term "error" (in keeping with the rest of the autopsy literature), the discrepancies between clinical and autopsy findings combine true errors with difficult cases. On the other hand, it is worth noting that these error rates do not include less dramatic but potentially important missed diagnoses, nor do they address delayed diagnosis. Diagnoses detected at any time before death were counted as clinically recognized even if earlier detection would have improved outcome.
These findings have important implications, especially for primary care physicians, who are most likely to be caring for patients at the end of life. Autopsy remains a diagnostic gold standard; failure to establish a cause of death is estimated to be less than 5 percent in adult deaths.6
With regard to inpatient deaths, it is tempting to assume that the barrage of sophisticated diagnostic tests readily available in contemporary hospitals obviates the need for autopsy. However, hospitalized patients accounted for the overwhelming majority of patients in the studies included in our analysis. Moreover, clinicians have only a modest ability to identify inpatient deaths in which autopsy will or will not yield important new information.6 With regard to outpatient deaths, the importance of autopsy is presumably greater, even in cases of apparently clear-cut sudden cardiac death.8
Physicians may worry about the possibility of malpractice claims, but the existing literature suggests that autopsy helps physicians more often than not.6 In fact, we found no reported case of malpractice action initiated solely on the basis of unexpected diagnostic errors or complications detected at autopsy. In a recent study assessing the role of autopsy information in malpractice cases, it was found that defendant physicians usually were exonerated, and observance of the standard of care was deemed more important in determining medical negligence than accuracy of clinical diagnosis.9
Although family members of a deceased patient sometimes worry about the potential effect of autopsy on funeral arrangements, it has virtually no effect on any aspect of a funeral. With appropriate notification to the pathologist, autopsy can be completed within 24 to 48 hours, and incisions on the face and head are difficult to detect even by the trained observer, creating no problems for open-casket ceremonies. Unfortunately, one issue of which clinicians in community practice need to remain aware is cost-in some regions, families must pay for nonforensic autopsies. Even in such regions, though, academic centers perform free autopsies and may accept referrals from other hospitals, because dwindling autopsy rates have made it difficult for pathology programs to provide access to sufficient cases for trainees.
Many physicians feel uncomfortable recommending autopsy to family members,10 presumably because of lack of experience because autopsy rates have fallen to such low levels.5 Criteria for autopsy referral are determined by the county or state. At the hospital level, each hospital is required to include autopsy criteria as part of its policy. As with advance directives and preferences for end-of-life care, autopsy discussions are generally less difficult than physicians initially imagine and can be rewarding, as patients express feelings about their illness and goals of care for the time they have left.
In interviews with family members of deceased patients who have undergone autopsy, it has been found that knowing the cause of death with certainty is comforting to the family, as is reassurance that a loved one received all that current medical care could provide.11
Kaveh G. Shojania, M.D., is assistant professor in the Department of Medicine, University of Cali-fornia, San Francisco.
Elizabeth C. Burton, M.D., is director of autopsy pathology in the Department of Pathology, Baylor Health Care System, Dallas.
Address correspondence to Kaveh G. Shojania, M.D., Department of Medicine, Box 0131, University of California, San Francisco, San Francisco, CA 94143. Reprints are not available from the authors.
REFERENCES
1. Goldman L, Sayson R, Robbins S, Cohn LH, Bettmann M, Weisberg M. The value of the autopsy in three medical eras. N Engl J Med 1983;308:1000-5.
2. Battle RM, Pathak D, Humble CG, Key CR, Vanatta PR, Hill RB, et al. Factors influencing discrepancies between premortem and postmortem diagnoses. JAMA 1987;258:339-44.
3. Kirch W, Schafii C. Misdiagnosis at a university hospital in 4 medical eras. Medicine [Baltimore] 1996; 75:29-40.
4. Sonderegger-Iseli K, Burger S, Muntwyler J, Salomon F. Diagnostic errors in three medical eras: a necropsy study. Lancet 2000;355:2027-31.
5. Burton EC, Nemetz PN. Medical error and outcomes measures: where have all the autopsies gone? MedGenMed 2000;2:E8. Accessed online March 4, 2004, at: http://www.medscape.com/viewarticle/408053. Requires previous (free) registration.
6. Shojania KG, Burton EC, McDonald KM, Goldman L. The autopsy as an outcome and performance measure (evidence report/technology assessment no. 58). Prepared by the UCSF-Stanford Evidence-based Practice Center, AHRQ publication no. 03-E001, October, 2002. Agency for Healthcare Research and Quality. Rockville, Md. Accessed online March 10, 2004, at: http://www.ahcpr.gov/clinic/epcsums/autopsum.htm.
7. Shojania KG, Burton EC, McDonald KM, Goldman L. Changes in rates of autopsy-detected diagnostic errors over time: a systematic review. JAMA 2003; 289:2849-56.
8. Lundberg GD, Voigt GE. Reliability of a presumptive diagnosis in sudden unexpected death in adults. The case for the autopsy. JAMA 1979;242:2328-30.
9. Bove KE, Iery C. Autopsy Committee, College of American Pathologists. The role of the autopsy in medical malpractice cases, I: a review of 99 appeals court decisions. Arch Pathol Lab Med 2002; 126:1023-31.
10. Rosenbaum GE, Burns J, Johnson J, Mitchell C, Robinson M, Truog RD. Autopsy consent practice at U.S. teaching hospitals: results of a national survey. Arch Intern Med 2000;160:374-80.
11. McPhee SJ, Bottles K, Lo B, Saika G, Crommie D. To redeem them from death. Reactions of family members to autopsy. Am J Med 1986;80:665-71.
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