- Email: [email protected]
Editorial Oversight of Results Reported in Annals
Correspondence
always be the case. Lumbar puncture is usually diagnostic for central nervous system infection and angiography is not. Conversely, angiography may identify a symptomatic aneurysm that has yet to rupture, whereas lumbar puncture cannot. Painful adverse effects are common after lumbar puncture. The risk of hemorrhage from lumbar puncture may outweigh the potential benefits in patients receiving anticoagulation. Allergic reaction or nephropathy after cerebrovascular imaging is rare. Ultimately, we concur with Probst and Hoffman.1 Both diagnostic algorithms are safe, with low risk of subsequent subarachnoid hemorrhage. The algorithm chosen by the emergency physician can be individualized according to patient presentation and educated patient preference. Lisa E. Thomas, MD Department of Emergency Medicine University of Maryland Upper Chesapeake Medical Center Bel Air, MD Amanda D. Czuczman, MD Department of Emergency Medicine Beverly Hospital Beverly, MA Keith A. Marill, MD, MS Department of Emergency Medicine Harvard Medical School Massachusetts General Hospital Boston, MA http://dx.doi.org/10.1016/j.annemergmed.2016.08.003
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. 1. Probst MA, Hoffman JR. Computed tomography angiography of the head is a reasonable next test after a negative noncontrast head computed tomography result in the emergency department evaluation of subarachnoid hemorrhage. Ann Emerg Med. 2016;67:773-774. 2. Chin N, Sarko J. Tried and true and still the best: lumbar puncture, not computed tomography angiogram, for the diagnosis of subarachnoid hemorrhage. Ann Emerg Med. 2016;67:774-775. 3. Czuczman AD, Thomas LE, Boulanger AB, et al. Interpreting red blood cells in lumbar puncture: distinguishing true subarachnoid hemorrhage from traumatic tap. Acad Emerg Med. 2013;20:247-256.
Volume 68, no. 6 : December 2016
4. Thomas LE, Czuczman AD, Boulanger AB, et al. Low risk for subsequent subarachnoid hemorrhage for emergency department patients with headache, bloody cerebrospinal fluid, and negative findings on cerebrovascular imaging. J Neurosurg. 2014;121:24-31. 5. Lin N, Zenonos G, Kim AH, et al. Angiogram-negative subarachnoid hemorrhage: relationship between bleeding pattern and clinical outcome. Neurocrit Care. 2012;16:389-398.
Editorial Oversight of Results Reported in Annals To the Editor: Because of the potential for enhanced compliance improving patient outcomes, I reviewed with interest the article by Rehrer et al1 reporting the results of their noninferiority trial evaluating a single dose of oral dexamethasone versus 5 days of oral prednisone in adults with acute asthma attacks. It was unfortunate that this logical concept did not pan out, but my greater disappointment was with their conclusion. In my role teaching evidence-based medicine to students, residents, and colleagues, it is imperative that editors ensure proper conveyance of information within the abstract. Without overcomplicating the issue, the study did not meet the predefined noninferiority margin; therefore, it was disappointing to see that the authors were allowed to qualify the findings by stating that the dexamethasone treatment missed the mark “by a very small margin.” I submit that the results should be communicated without subjective verbiage. This was followed by a suggestion that “regardless” of the lack of benefit on clinical outcomes, the readers should consider dexamethasone because of the convenience factor. This was a great concept with a lot of potential. Most clinicians—and editors are among that group—are very busy running their practices, so the ability to receive concise and accurately reported findings is a major benefit. I implore the busy editorial staff to redouble their efforts to provide clinicians with the best possible objective reporting of data within Annals. Michael P. Carson, MD Department of Medicine Jersey Shore University Medical Center Neptune, NJ Departments of Medicine and Obstetrics, Gynecology and Reproductive Sciences Rutgers–Robert Wood Johnson Medical School New Brunswick, NJ http://dx.doi.org/10.1016/j.annemergmed.2016.08.439
Annals of Emergency Medicine 787
Correspondence
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The author has stated that no such relationships exist. 1. Rehrer MW, Liu B, Rodriguez M, et al. A randomized controlled noninferiority trial of single dose of oral dexamethasone versus 5 days of oral prednisone in acute adult asthma. Ann Emerg Med. 2016; http://dx.doi.org/10.1016/j.annemergmed.2016.03.017.
Given these principles, we encouraged the authors to openly communicate the equivocal nature of their outcome. Our Editor’s Capsule Summary stated that “[a] single dose of oral dexamethasone 12 mg is either similar to or slightly inferior to a 5-day course of prednisone 60 mg for asthma.” A black-and-white interpretation of what are often nuanced research findings is not a necessary or desirable component of evidence-based medicine. In fact, many argue that modern evidence-based medicine must go beyond frequentist statistical approaches to overtly adjust for study bias and selection of study bias.3,4
In reply: Dr. Carson disagrees with a qualified conclusion for the noninferiority trial by Rehrer et al.1 In this study, the 95% confidence intervals for the outcome overlapped the prespecified noninferiority threshold, and therefore Dr. Carson argues that noninferiority is rejected and that the conclusion should simply state this negative result. Specifically for this study, single-dose dexamethasone should not be considered as effective as 5 days of prednisone for asthma. Dr. Carson represents the behaviorist approach to classic statistical analysis, in which one relies on hypothesis testing and arbitrary thresholds to accept or reject a hypothesis.2 Unfortunately, research outcomes are not always so neatly positive or negative. There are periodically highquality trials with borderline results. The study by Rehrer et al1 is a classic example, with the relapse size of effect being 2.3%, with 95% confidence intervals (–4.1% to 8.6%) that barely cross their prespecified 8% margin. As editors, should we unconditionally reject noninferiority according to this trivial 0.6% overlap? Should we not recognize that, for some readers, 9% might be a reasonable clinically important margin—a scenario in which a similarly rigid interpretation would abruptly reverse the study conclusion, or that other readers are interested in the general magnitude of the outcome without feeling forced to call the study results positive or negative?
788 Annals of Emergency Medicine
Steven M. Green, MD Annals of Emergency Medicine Loma Linda University Loma Linda, CA David L. Schriger, MD, MPH Annals of Emergency Medicine University of California, Los Angeles Los Angeles, CA http://dx.doi.org/10.1016/j.annemergmed.2016.08.441
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. 1. Rehrer MW, Liu B, Rodriguez M, et al. A randomized controlled noninferiority trial of single dose of oral dexamethasone versus 5 days of oral prednisone in acute adult asthma. Ann Emerg Med. 2016; http://dx.doi.org/10.1016/j.annemergmed.2016.03.017. 2. Schriger DL. Problems with current methods of data analysis and reporting, and suggestions for moving beyond incorrect ritual. Eur J Emerg Med. 2002;9:203-207. 3. Greenland S. Multiple-bias modeling for analysis of observational data (with discussion). J R Stat Soc. 2005;168:267-308. 4. Turner RM, Spiegelhalter DJ, Smith GCS, et al. Bias modelling in evidence synthesis. J R Stat Soc. 2009;172:21-47.
Volume 68, no. 6 : December 2016
always be the case. Lumbar puncture is usually diagnostic for central nervous system infection and angiography is not. Conversely, angiography may identify a symptomatic aneurysm that has yet to rupture, whereas lumbar puncture cannot. Painful adverse effects are common after lumbar puncture. The risk of hemorrhage from lumbar puncture may outweigh the potential benefits in patients receiving anticoagulation. Allergic reaction or nephropathy after cerebrovascular imaging is rare. Ultimately, we concur with Probst and Hoffman.1 Both diagnostic algorithms are safe, with low risk of subsequent subarachnoid hemorrhage. The algorithm chosen by the emergency physician can be individualized according to patient presentation and educated patient preference. Lisa E. Thomas, MD Department of Emergency Medicine University of Maryland Upper Chesapeake Medical Center Bel Air, MD Amanda D. Czuczman, MD Department of Emergency Medicine Beverly Hospital Beverly, MA Keith A. Marill, MD, MS Department of Emergency Medicine Harvard Medical School Massachusetts General Hospital Boston, MA http://dx.doi.org/10.1016/j.annemergmed.2016.08.003
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. 1. Probst MA, Hoffman JR. Computed tomography angiography of the head is a reasonable next test after a negative noncontrast head computed tomography result in the emergency department evaluation of subarachnoid hemorrhage. Ann Emerg Med. 2016;67:773-774. 2. Chin N, Sarko J. Tried and true and still the best: lumbar puncture, not computed tomography angiogram, for the diagnosis of subarachnoid hemorrhage. Ann Emerg Med. 2016;67:774-775. 3. Czuczman AD, Thomas LE, Boulanger AB, et al. Interpreting red blood cells in lumbar puncture: distinguishing true subarachnoid hemorrhage from traumatic tap. Acad Emerg Med. 2013;20:247-256.
Volume 68, no. 6 : December 2016
4. Thomas LE, Czuczman AD, Boulanger AB, et al. Low risk for subsequent subarachnoid hemorrhage for emergency department patients with headache, bloody cerebrospinal fluid, and negative findings on cerebrovascular imaging. J Neurosurg. 2014;121:24-31. 5. Lin N, Zenonos G, Kim AH, et al. Angiogram-negative subarachnoid hemorrhage: relationship between bleeding pattern and clinical outcome. Neurocrit Care. 2012;16:389-398.
Editorial Oversight of Results Reported in Annals To the Editor: Because of the potential for enhanced compliance improving patient outcomes, I reviewed with interest the article by Rehrer et al1 reporting the results of their noninferiority trial evaluating a single dose of oral dexamethasone versus 5 days of oral prednisone in adults with acute asthma attacks. It was unfortunate that this logical concept did not pan out, but my greater disappointment was with their conclusion. In my role teaching evidence-based medicine to students, residents, and colleagues, it is imperative that editors ensure proper conveyance of information within the abstract. Without overcomplicating the issue, the study did not meet the predefined noninferiority margin; therefore, it was disappointing to see that the authors were allowed to qualify the findings by stating that the dexamethasone treatment missed the mark “by a very small margin.” I submit that the results should be communicated without subjective verbiage. This was followed by a suggestion that “regardless” of the lack of benefit on clinical outcomes, the readers should consider dexamethasone because of the convenience factor. This was a great concept with a lot of potential. Most clinicians—and editors are among that group—are very busy running their practices, so the ability to receive concise and accurately reported findings is a major benefit. I implore the busy editorial staff to redouble their efforts to provide clinicians with the best possible objective reporting of data within Annals. Michael P. Carson, MD Department of Medicine Jersey Shore University Medical Center Neptune, NJ Departments of Medicine and Obstetrics, Gynecology and Reproductive Sciences Rutgers–Robert Wood Johnson Medical School New Brunswick, NJ http://dx.doi.org/10.1016/j.annemergmed.2016.08.439
Annals of Emergency Medicine 787
Correspondence
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The author has stated that no such relationships exist. 1. Rehrer MW, Liu B, Rodriguez M, et al. A randomized controlled noninferiority trial of single dose of oral dexamethasone versus 5 days of oral prednisone in acute adult asthma. Ann Emerg Med. 2016; http://dx.doi.org/10.1016/j.annemergmed.2016.03.017.
Given these principles, we encouraged the authors to openly communicate the equivocal nature of their outcome. Our Editor’s Capsule Summary stated that “[a] single dose of oral dexamethasone 12 mg is either similar to or slightly inferior to a 5-day course of prednisone 60 mg for asthma.” A black-and-white interpretation of what are often nuanced research findings is not a necessary or desirable component of evidence-based medicine. In fact, many argue that modern evidence-based medicine must go beyond frequentist statistical approaches to overtly adjust for study bias and selection of study bias.3,4
In reply: Dr. Carson disagrees with a qualified conclusion for the noninferiority trial by Rehrer et al.1 In this study, the 95% confidence intervals for the outcome overlapped the prespecified noninferiority threshold, and therefore Dr. Carson argues that noninferiority is rejected and that the conclusion should simply state this negative result. Specifically for this study, single-dose dexamethasone should not be considered as effective as 5 days of prednisone for asthma. Dr. Carson represents the behaviorist approach to classic statistical analysis, in which one relies on hypothesis testing and arbitrary thresholds to accept or reject a hypothesis.2 Unfortunately, research outcomes are not always so neatly positive or negative. There are periodically highquality trials with borderline results. The study by Rehrer et al1 is a classic example, with the relapse size of effect being 2.3%, with 95% confidence intervals (–4.1% to 8.6%) that barely cross their prespecified 8% margin. As editors, should we unconditionally reject noninferiority according to this trivial 0.6% overlap? Should we not recognize that, for some readers, 9% might be a reasonable clinically important margin—a scenario in which a similarly rigid interpretation would abruptly reverse the study conclusion, or that other readers are interested in the general magnitude of the outcome without feeling forced to call the study results positive or negative?
788 Annals of Emergency Medicine
Steven M. Green, MD Annals of Emergency Medicine Loma Linda University Loma Linda, CA David L. Schriger, MD, MPH Annals of Emergency Medicine University of California, Los Angeles Los Angeles, CA http://dx.doi.org/10.1016/j.annemergmed.2016.08.441
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. 1. Rehrer MW, Liu B, Rodriguez M, et al. A randomized controlled noninferiority trial of single dose of oral dexamethasone versus 5 days of oral prednisone in acute adult asthma. Ann Emerg Med. 2016; http://dx.doi.org/10.1016/j.annemergmed.2016.03.017. 2. Schriger DL. Problems with current methods of data analysis and reporting, and suggestions for moving beyond incorrect ritual. Eur J Emerg Med. 2002;9:203-207. 3. Greenland S. Multiple-bias modeling for analysis of observational data (with discussion). J R Stat Soc. 2005;168:267-308. 4. Turner RM, Spiegelhalter DJ, Smith GCS, et al. Bias modelling in evidence synthesis. J R Stat Soc. 2009;172:21-47.
Volume 68, no. 6 : December 2016