Easier Breathing?

Easier Breathing?

Editorials Dueling Meta-Analyses Address for reprints: Robert M. Williams MD, DrPH, School of Public Health, University of Michigan, 1420 Washington...

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Editorials

Dueling Meta-Analyses

Address for reprints: Robert M. Williams MD, DrPH, School of Public Health, University of Michigan, 1420 Washington Heights, Ann Arbor, MI 48109-2029;

Robert L. Wears, MD, MS

231-938-2494, fax 231-938-0364; E-mail [email protected].

Department of Emergency Medicine University of Florida Health Science Center

47/1/109212 doi:10.1067/mem.2000.109212

Jacksonville, FL Address for reprints: Robert L. Wears, MD, MS, Department of Emergency Jacksonville, FL 32209; 904-549-4124, 904-549-4508; E-mail [email protected].

Emergency Departments and Uninsured Children: An Enrollment Opportunity

47/1/109692

Susan M. Nedza, MD

doi:10.1067/mem.2000.109692

Chair, Legislative and Regulatory Committee

Medicine, University of Florida Health Science Center, 655 West 8th Street,

American College of Emergency Physicians

Easier Breathing?

Irving, TX

Rita K. Cydulka, MD

Deborah Mulligan-Smith, MD

Department of Emergency Medicine

Committee on Pediatrics

MetroHealth Medical Center

American College of Emergency Physicians

Case Western Reserve University

Irving, TX

Cleveland, OH

Russell Harris, MD

Reprints not available from the author. Address for correspondence: Rita K. Cydulka, MD, Department of Emergency Medicine, MetroHealth Medical Center, Room S1-203, Cleveland, OH 44109; 216-778-5088; E-mail [email protected].

Immediate Past-President New Jersey Chapter American College of Emergency Physicians Trenton, NJ Address for reprints: Susan M. Nedza, MD, Department of Emergency

47/1/109687 doi:10.1067/mem.2000.109687

Medicine, Elmhurst Memorial Hospital, 200 Berteau, Elmhurst, IL 60126; fax 630-986-9443; E-mail [email protected].

The Prudent Layperson Definition: Will It Work for Emergency Medicine?

47/1/109448 doi:10.1067/mem.2000.109448 Copyright © 2000 by the American College of Emergency Physicians.

Robert M. Williams, MD, DrPH

0196-0644/2000/$12.00 + 0

Department of Health Management and Policy University of Michigan School of Public Health Ann Arbor, MI

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EDITORIALS

6. Juni P, Witschi A, Bloch R, et al. The hazards of scoring the quality of clinical trials for metaanalysis [see comments]. JAMA. 1999;282:1054-1060. 7. Chalmers TC, Celano P, Sacks HS, et al. Bias in treatment allocation in controlled clinical trials. N Engl J Med. 1983;309:1358-1361. 8. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. JAMA. 1995;273:408-412. 9. Moher D, Pham B, Jones A, et al. Does the quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-613. 10. Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999;282:1061-1066. 11. Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Engl J Med. 1980;303:1038-1041. 12. Greenland S. Quality scores are useless and potentially misleading. Am J Epidemiol. 1994;140:300-301. 13. Berlin JA, Rennie D. Measuring the quality of trials: the quality of quality scales [editorial; comment]. JAMA. 1999;282:1083-1085. 14. Greenland S. Invited commentary: a critical look at some popular meta-analytic methods [see comments]. Am J Epidemiol. 1994;140:290-296. 15. Thompson SG. Why sources of heterogeneity in meta-analysis should be investigated. BMJ. 1994;309:1351-1355. 16. Pocock S. Meta-analysis [editorial]. Stat Methods Med Res. 1993;2:117-119. 17. Boissel JP, Blanchard J, Panak E, et al. Considerations for the meta-analysis of randomized clinical trials. Summary of a panel discussion. Control Clin Trials. 1989;10:254-281. 18. L’Abbé KA, Detsky AS, O’Rourke K. Meta-analysis in clinical research. Ann Intern Med. 1987;107:224-233. 19. Hedges LV, Olkin I. Statistical Methods for Meta-Analysis. New York, NY: Academic Press; 1985. 20. Cooper H, Hedges LV, eds. Handbook of Research Synthesis. New York, NY: Russell Sage Foundation; 1994. 21. Greenland S. Quantitative methods in the review of epidemiologic literature. Epidemiol Rev. 1987;9:1-30. 22. Greenland S, Schlesselman JJ, Criqui MH. The fallacy of employing standardized regression coefficients and correlations as measures of effect. Am J Epidemiol. 1986;123:203-208.

Easier Breathing? See related article, p. 198. [Cydulka RK. Easier breathing? Ann Emerg Med. September 2000;36:236-238.] Asthma affects 4% to 5% of the population in the United States and accounts for approximately 2 million visits to the nation’s emergency departments.1,2 Although asthma is a chronic illness that is usually easily managed with proper ongoing, comprehensive ambulatory care, much of its economic impact is associated with asthma exacerbation, ED use, and hospitalization, which is likely a result of a failure of our medical system to provide the aforementioned ongoing care.2 As a result of the increasing prevalence and impact of asthma on both the adult and pediatric population, much time and energy has been devoted to its study. A quick computerized literature search of PubMed yielded 1,311 articles related to “asthma

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AND emergency treatment” since 1990.3 The proliferation of asthma-related research and literature has helped promote and publicize the understanding that asthma is largely a chronic inflammatory disorder (or group of disorders) rather than an episodic bronchospastic event and has served to formulate the guidelines that direct our current treatment of asthma.4-9 Despite the recognition of asthma as an inflammatory disorder and the ongoing quest to determine the optimal method of reducing inflammation in asthmatic patients, bronchodilation with β2-agonists remains an essential ingredient in the therapeutic armamentarium for emergency physicians, who primarily treat asthmatic patients with acute exacerbation, rather than managing chronic disease. Many questions still remain regarding the use of β-agonists in the treatment of acute exacerbation. For example, researchers have not determined whether a single β-agonist agent is superior to the others; nor have they resolved whether isomers of β-agonists are superior to the racemic versions of the drug. Also unresolved are the problems of optimal dosing, optimal methods of delivery, timing of delivery, as well as a myriad of other issues regarding both treatment efficacy and effectiveness. The result is that treatment choices recommended by current guidelines are left somewhat open-ended.6-9 In 1997, the National Institutes of Health National Asthma Education and Prevention Program revised its guidelines based on several well-conducted clinical trials to suggest that asthmatic patients experiencing a severe exacerbation can be treated with inhaled high-dose β-agonists by either nebulization every 20 minutes or continuously for 1 hour.6,10,11 The use of continuous albuterol nebulization was first reported in 14 children in 1987, where high-dose continuous nebulization was shown to produce a greater improvement in FEV1 than intermittent-dose albuterol or bolus-dose albuterol followed by a lower continuous dose.12 Although 2 early reports indicated that improvement in pulmonary function tests persisted longer in patients treated with continuous nebulization than in those treated with intermittent treatment,13,14 the study by Scalabrin et al15 of 21 children with acute asthma did not support these findings. Papo et al16 later found that children with severe asthma unresponsive to conventional treatment who were subsequently treated with continuous nebulization demonstrated a more rapid clinical improvement in asthma and had shorter hospital stays than those treated with intermittent β-agonist therapy. The option of continuous nebulization of albuterol was first described in adults as a case report in 1990.17

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Unlike the pediatric clinical trials, which were conducted primarily in an intensive care setting, the subsequent trials in adults focused on the treatment of acute asthma exacerbation in the ED. Early trials revealed no difference in pulmonary function at the end of a 2-hour observation period among patients treated with continuous nebulization or intermittent albuterol.18 Two later trials also reported no differences in response between adults treated with continuous nebulization or intermittent albuterol, although—based on post hoc analyses—they reported that patients with severe obstruction responded more favorably with continuous nebulization and required fewer hospital admissions.10,11 The conclusions of Rudnitsky et al10 were based on statistically significant, but clinically insignificant, differences in peak expiratory flow rate (PEFR) between groups after completion of treatment. Lin et al’s11 conclusions were determined by the rate of improvement of percent predicted FEV1 rather than differences in improvement of pulmonary function after treatment was completed. In this issue of Annals, Besbes-Ouanes et al19 present the first study comparing continuous versus intermittent nebulized β-agonist agents in patients with severe exacerbation (PEFR <50% predicted). Their study design differed from the others in several ways: (1) the dosing scheme and duration of continuous albuterol called for 27.4 mg of salbutamol over 6 hours rather than lower doses over a shorter period; (2) they used a standard ED small-reservoir nebulizer for both the continuous and the intermittent groups rather than a small-reservoir nebulizer for the intermittent group and a large-reservoir nebulizer for the continuous group; and (3) they included clinical severity, time to improvement, spirometric values, failure to improve rate, and side effects as their outcome measures rather than simply comparing pulmonary function values. Unlike the investigators who preceded them, Besbes-Ouanes et al reported that continuous β-agonist therapy performed no better than did intermittent nebulization treatments for patients with severe asthma with regard to clinical symptoms and scores, pulmonary function, side effects, and need for hospitalization. Unfortunately, as the authors noted, the study was insufficiently powered to detect differences in treatment failure and hospitalization rates. Does this study close the door on this issue? Au contraire, it opens the door to further investigation. First, would Besbes-Ouanes et al19 have found important clinical differences between the 2 modalities if their study had been sufficiently powered? Second, are the size and kind of reservoir and nebulizer used for continuous therapy

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important? Might their results have differed if they had used a standard large-chambered reservoir for the continuous therapy group? Only a large, 3-armed trial of patients with severe obstructive asthma that compares intermittent nebulization using a small reservoir with continuous nebulization using a small reservoir and continuous nebulization using large reservoir will provide the information that we seek. Despite these unanswered questions, Besbes-Ouanes et al have provided the reassurance that continuous-dose β-agonist therapy is as effective as intermittent-dose therapy, which is a relief for emergency physicians treating asthmatic patients in busy EDs, where only one size reservoir may be available, and respiratory therapists may not be available for the care of “routine” asthmatic patients, and nurses are so busy that providing a fresh dose of β-agonist every 20 minutes may be an unrealistic expectation. Although the goal of this study and the thousands of other studies routinely performed on patients with acute asthma exacerbation was to determine how to optimize emergency treatment of acute asthma, it, and most others, failed to address a more urgent issue: that is, the recognition that asthma is a chronic problem whose long-term control and consequences must be addressed in the ED. Although it is certainly crucial to provide optimal care in the ED, it makes little difference whether continuous β-agonist therapy is better than intermittent β-agonist therapy if we fail to provide asthmatic patients with proper discharge medications, are unable to arrange prompt follow-up for all asthmatic patients discharged from the ED, and we do not teach asthmatic patients with acute exacerbation how to care for themselves on a daily basis.20-23 The goal of our research should be multifaceted: improve emergency therapy, bridge the gap between emergency therapy and primary care, and instruct our patients about the possibility of effectively managing their disease so that they rarely require a visit to the ED for an acute attack. It is in these areas that we should now strive to advance the care of asthma in the ED. It’s time we recognize that an asthma exacerbation represents an opportunity to make a significant intervention in the care of a patient with a chronic disease and a chance to work in concert with our colleagues in internal medicine, family practice, pulmonary medicine, and allergy and immunology who provide the long-term ambulatory care for asthmatic patients. In the meantime, however, Besbes-Ouanes et al19 have elegantly demonstrated that the simpler decision of whether to use continuous or intermittent β-agonist therapy in the ED treatment of patients with severe obstruc-

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tive asthma will remain one of preference, convenience, and availability of equipment and staffing. 1. Weiss ST, Speizer FE. Epidemiology and natural history. In: Weiss E, Stein M, eds. Bronchial Asthma: Mechanisms and Therapeutics. Boston, MA: Little, Brown; 1993:15-25. 2. Weiss KB, Gergen PJ, Hodgson TA. An economic evaluation of asthma in the United States. N Engl J Med. 1992;326:862-866. 3. PubMed. Available at: http://www.ncbi.nlm.nih.gov/PubMed/. 4. Anonymous. Guidelines on the management of asthma. Thorax. 1993;48(Suppl):S1-S24. 5. Emond SD, Camargo CA Jr, Nowak RM. 1997 National Asthma Education and Prevention Program guidelines: a practical summary for emergency physicians. Ann Emerg Med. 1998;31:579-589. 6. National Asthma Education and Prevention Program. Expert Panel Report II: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National Institutes of Health; 1997. 7. Guidelines for the management of asthma: a summary. British Thoracic Society and others [see comments] [published erratum appears in BMJ. 1993;307:1054]. BMJ. 1993;306:776-782. 8. Guidelines on the management of asthma. Statement by the British Thoracic Society, the British Paediatric Association, the Research Unit of the Royal College of Physicians of London, the King’s Fund Centre, the National Asthma Campaign, the Royal College of General Practitioners, the General Practitioners in Asthma Group, the British Association of Accident and Emergency Medicine, and the British Paediatric Respiratory Group [see comments] [published errata appear in Thorax. 1994 Jan;49(1):96 and 1994 Apr;49(4):386]. Thorax. 1993;48:S1-24. 9. Beveridge RC, Grunfeld AF, Hodder RV, et al. Guidelines for the emergency management of asthma in adults. CAEP/CTS Asthma Advisory Committee. Canadian Association of Emergency Physicians and the Canadian Thoracic Society. CMAJ. 1996;55:25-37. 10. Rudnitsky GS, Eberlein RS, Schoffstall JM, et al. Comparison of intermittent and continuously nebulized albuterol for treatment of asthma in an urban emergency department. Ann Emerg Med. 1993;22:1842-1846. 11. Lin RY, Sauter D, Newman T, et al. Continuous versus intermittent albuterol nebulization in the treatment of acute asthma. Ann Emerg Med. 1993;22:1847-1853. 12. Ba M, Thivierge RL, Lapierre JG, et al. The bronchodilator response to inhalation of increasing doses of aerosolized albuterol [abstract]. Am Rev Respir Dis. 1987;135:A326. 13. Salazar RO, Joos TH, Nichles PA, et al. Treatment of status asthmaticus with continuous nebulized albuterol therapy in children [abstract]. J Allergy Clin Immunol. 1990;85:196. 14. Amado M, Portnoy J, King K. Comparison of bolus and continuously nebulized albuterol for treatment of exacerbations of asthma [abstract]. J Allergy Clin Immunol. 1988;1:318. 15. Scalabrin DM, Sole D, Naspitz CK. Efficacy and side effects of beta 2-agonists by inhaled route in acute asthma in children: comparison of salbutamol, terbutaline, and fenoterol. J Asthma. 1996;33:407-415. 16. Papo MC, Frank J, Thompson AE. A prospective, randomized study of continuous versus intermittent nebulized albuterol for severe status asthmaticus in children. Crit Care Med. 1993;21:1479-1486. 17. Voss KR, Willsie-Ediger SK, Pyszczynski DR, et al. Description of a delivery method for continuously aerosolized albuterol in status asthmaticus. J Asthma. 1990;27:37-39. 18. Colacone A, Wolkove N, Stern E, et al. Continuous nebulization of albuterol (salbutamol) in acute asthma. Chest. 1990;97:693-697. 19. Besbes-Ouanes L, Nouira S, Elatrous S, et al. Continuous versus intermittent nebulization of salbutamol in acute severe asthma: a randomized, controlled trial. Ann Emerg Med. 2000;36:198-203. 20. Emerman CL, Woodruff PG, Cydulka RK, et al. Prospective multicenter study of relapse following treatment for acute asthma among adults presenting to the emergency department. MARC investigators. Multicenter Asthma Research Collaboration [see comments]. Chest. 1999;115:919-927. 21. Emerman CL, Cydulka RK, Skobeloff E. Survey of asthma practice among emergency physicians. Chest. 1996;109:708-712. 22. Emerman CL, Cydulka RK. Factors associated with relapse after emergency department treatment for acute asthma. Ann Emerg Med. 1995;26:6-11. 23. Emond SD, Reed CR, Graff LG, et al. Asthma education in the emergency department [abstract]. Acad Emerg Med. 1999;34(4 Pt 2):S95-S96.

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The Prudent Layperson Definition: Will It Work for Emergency Medicine? See related article, p. 212. [Williams RM. The prudent layperson definition: will it work for emergency medicine? Ann Emerg Med. September 2000;36:238240.] Passage of prudent layperson legislation has been a major focus of organized emergency medicine in recent years. About 30 states have passed such legislation, and the prudent layperson definition is included in the Balanced Budget Act of 1997 for Medicaid and Medicare patients. Many emergency physicians consider this language to be a solution to the reimbursement issues involving managed care. In this issue of Annals, Shesser et al1 present their findings regarding classification of emergency department visits as a presenting symptom–based system based on the prudent layperson criteria, compared with final diagnosis–based system used by a managed care organization (MCO). This is an interesting and important study in that it provides an examination of how application of the prudent layperson standard might work in practice. For decades, emergency physicians accepted the premise that patients were the best judges of their welfare. Hospitals and emergency physicians were absolved of any responsibility of classification of medical necessity by accepting that everyone who showed up at the ED, by patient definition, was a legitimate emergency visit. In recent years, the phenomenal growth of managed care and the use of stringent retrospective criteria to determine payment for emergency services have rendered this deemed approach invalid, and have resulted in conflict between emergency physicians and MCOs. A major issue for emergency physicians is whether the prudent layperson language will resolve these reimbursement issues. The article appearing in the current issue of this journal gives a first look of how the prudent layperson approach might function with regard to defining an insurable event. What is a medical emergency? Although there has been increasing interest among emergency physicians, policymakers, and insurers in defining ED use by level of the patient’s condition severity, there are no accepted standard classification criteria for determining patient urgency. During the past 40 years, numerous authors have used a variety of objective and subjective criteria to classify ED patients as urgent or nonurgent.2-16 Many policymakers

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