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      Enhancing the research experience through peer-reviewed literature

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      International Journal of Emergency Medicine
      Springer-Verlag

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          Abstract

          Dear Editors, Your article “Clinical research 101: Why should you care?” [1] was very interesting and I applaud the journal, which in its infancy is addressing issues such as importance of clinical research. As you correctly mention, the emergency department (ED) is a clinical laboratory, and clinical research apart from answering some of the most pertinent questions has the additional value of being immediately relevant to patient care. As a research director of a very busy pediatric ED with an active fellowship in pediatric emergency medicine, I am constantly struggling to convey the message that research is not an entity which gets conducted solely in laboratories or demands extensive knowledge of statistics to my colleagues. Research is a very important step in improving patient care by applying what is known to the patient immediately in front of you. Research provides the foundation for evidence-based medicine and the tools for evidence-based practice. I would also add that research can vary in its quality and comprehensiveness. Practitioners of emergency medicine must be discerning enough to critically appraise research as there are many instances of “published” studies that either lack the appropriate methodology, adequate sample size, or rigorous analysis. Additionally, research is constantly evolving and what is considered as gospel may be eventually refuted with a well-conducted study. Use of steroids in bronchiolitis is an example. A well-conducted double-blinded randomized controlled trial (n = 70) performed at one ED comparing a single dose of oral dexamethasone with a placebo in children with moderate to severe bronchiolitis showed a substantial reduction in hospitalization along with clinical improvement. This study was powered to detect a difference in a clinical score not rates of hospitalization [2]. Yet, using these efficacy data, many practitioners changed their practice and started using oral dexamethasone in the management of bronchiolitis. A subsequent larger, multicenter study (effectiveness study) showed no effect of a single dose of oral dexamethasone when the study was powered to detect a 12% difference in admission rates (n = 600). This second study clearly showed that there was no difference in hospitalization rates [3]. The challenge now is to disseminate these findings—translating research into practice (TRIP). In conclusion, I think it is important for journals such as yours to enhance the research experience by (a) publishing articles on research methodology, (b) being more discerning as to which articles get accepted, and (c) broadening the scope of emergency research by publishing articles on research ethics in varied settings, i.e., international emergency medicine.

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          A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

          Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
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            Efficacy of oral dexamethasone in outpatients with acute bronchiolitis.

            To examine the efficacy of oral dexamethasone in acute bronchiolitis. A double-blind randomized, placebo-controlled trial involving 70 children or = 6. Each patient received either 1 dose of 1 mg/kg of oral dexamethasone or placebo and was assessed hourly for a 4-hour period. Repeated measures regression analysis evaluated a change in the Respiratory Assessment Change Score (RACS). The 2 groups had similar baseline characteristics with Respiratory Disease Assessment Inventory of 9.4 +/- 2.3 in the dexamethasone group (n = 36) and 10.0 +/- 2.7 in the placebo group (n = 34). The RACS was -5.0 +/- 3.1 in the dexamethasone group and -3.2 +/- 3.7 in the placebo group (P =.029). Poor RACS occurred in 41% and 17% of the placebo and dexamethasone groups, respectively (P =.034). Of the children treated with dexamethasone, 19% were hospitalized compared with 44% in the placebo group (P =.039). There was no difference in RACS between the groups on day 7 (P =.75). Outpatients with moderate-to-severe acute bronchiolitis derive significant clinical and hospitalization benefit from oral dexamethasone treatment in the initial 4 hours of therapy.
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              Clinical research 101: Why should you care?

              In this issue’s Clinical Research Capsule, we ask the fundamental question: “Why care about research?” Clinicians sometimes have a distanced attitude towards research. The reasons for this are many: conducting research is difficult; it is only for those who are statistically minded; it means having NIH or equivalent funding; finally, it does not pertain to them as research is separate from patient care. The notion that research is separate and without impact on patient care could not be more erroneous. Let’s look at a few examples: You are evaluating a patient with an acute ankle injury. Do you recognize the following questions? Unable to bear weight immediately and in ED? Tender on the lateral malleolar tip or posterior aspect of the lateral malleolus? Tender on the medial malleolar tip or posterior aspect of the medial malleolus? Most practicing emergency medicine clinicians will recognize these as the questions used for the Ottawa ankle rule [1]. This was a prospective survey administered in two stages: derivation and refinement of the original rules (first stage) and validation of the refined rules (second stage). The cohort consisted of a convenience sample of adults with acute ankle injuries: 1,032 of 1,130 eligible patients in the first stage and 453 of 530 eligible patients in the second stage. While these research method details may seem not useful to daily clinical practice, the results derived from this study certainly are. What about the following physical exam findings? No posterior midline cervical-spine tenderness No evidence of intoxication A normal level of alertness No focal neurologic deficit No painful distracting injuries The above represent the NEXUS low risk criteria, which state that if a patent has all of the above, then they do not require cervical spine radiography [2]. This prospective observational study was conducted across 21 centers in the US. The study population consisted of 34,069 patients evaluated by imaging of the cervical spine after blunt trauma. Of these, 2.4% had radiographically documented cervical-spine injury. These results yielded an overall sensitivity of 99%, specificity of 12.9%, and a negative predictive value of 99.8%. Again, while conducting such a study may not appeal to everyone, the results from such investigations do impact everyday patient care. If the above two examples haven’t convinced you clinical research directly impacts patient care, consider the following case: A 45-year-old male presents to the ED with chest pain of 2.5-h duration, radiating to the left arm, associated with diaphoresis, relieved by sublingual nitroglycerin in the ambulance, and rated 5/10. Family history is unknown. What blood test will you order? The troponin story [3]: 855 patients with symptoms of acute myocardial ischemia within 12 h of onset had serum troponin T, CK-MB, and ECG done and analyzed in blinded fashion. Logistic regression was used to assess the usefulness of baseline levels of troponin T and CK-MB vs. ECG findings (ST-segment elevation, ST-segment depression, T-wave inversion, or the presence of confounding factors that impair the detection of ischemia). On admission, 289 of 801 patients with base-line serum samples had elevated troponin T. Mortality within 30 days was significantly higher in these patients than in patients with lower levels of troponin T (11.8% vs. 3.9%, P < 0.001). Troponin T levels remained significantly predictive of 30-day mortality in a model that contained ECG categories and CK-MB levels (chi-square = 9.2, P = 0.027). The authors of the study concluded that cardiac troponin T level is a powerful, independent risk marker in patients who present with acute myocardial infarction. Today, most clinicians routinely use this serum marker, perhaps not thinking about its origins from a research study. So, why care about clinical research? Clinical research is the way in which we can scientifically study patient outcomes and thus deliver evidence-based care. Our ED is our laboratory—where we are continually gathering, classifying, and analyzing data. While basic science and animal studies can provide important clues to the underlying pathophysiology of many human ailments, some nuances of human disease are not translatable from these models. Referred to as “the youngest science” by Lewis Thomas, the wonders of modern medicine are a direct result of medical research. Being involved in research offers the clinician the satisfaction of discovery and contributing to the care of those beyond the reach of her touch. “The real voyage of discovery consists not in seeking new landscapes, but in having new eyes.” -Marcel Proust
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                Author and article information

                Contributors
                +1-313-7455260 , +1-313-9937166 , pmahajan@dmc.org
                Journal
                Int J Emerg Med
                International Journal of Emergency Medicine
                Springer-Verlag (London )
                1865-1372
                1865-1380
                22 August 2008
                22 August 2008
                September 2008
                : 1
                : 3
                : 233
                Affiliations
                Pediatric Emergency Medicine, Carman & Ann Adams Department of Pediatrics, Children’s Hospital of Michigan, Detroit, MI 48201 USA
                Article
                48
                10.1007/s12245-008-0048-9
                2657282
                19384528
                fdb1ce0d-1020-49c8-bb38-cd2b09a3b149
                © Springer-Verlag London Ltd 2008
                History
                : 9 July 2008
                : 18 July 2008
                Categories
                Letter to the Editor
                Custom metadata
                © Springer-Verlag London Ltd 2008

                Emergency medicine & Trauma
                Emergency medicine & Trauma

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