- Email: [email protected]
In Reply: EMS Research
CORRESPONDENCE
EMS Research To the Editor: Dr Callaham's excellent article' reviewing the very small number of randomized controlled trials in the EMS literature serves as a notso-gentle reminder that most of the therapies delivered on the streets every day by our EMS systems are unsupported by science. But we believe it is extremely important to recognize that traditional clinical trials may not be the best model for EMS research. Indeed, as Spaite has explained more clearly than we ever could, 2 systems research and not component research must be the future in EMS. It is very difficult to carry the traditional medical research model to the field-so difficult, in fact, that Spaite suggests that inaccurate conclusions are often drawn as a result of inherent limitations in the model and its flawed application to the uncontrolled out-of-hospital environment. Spaite suggests that this component research should be abandoned altogether, in favor of systems research, which draws on multidisciplinary models from such diverse fields as behavioral science, public health, economics, and epidemiology to study entire systems, not just individual components of those systems. Application of these models to EMS will clearly be difficult, since most physicians are not familiar with, never mind formally trained in, these models-yet we must accept Spaite's challenge and take the systems path if we are to prove (or disprove) the value of EMS. The outstanding article by Maio and Spaite 3 on the ecologic study serves as an example of how EMS researchers can adopt and adapt some of these diverse methodologies for the study of out-of-hospital care. What we need now is a flurry of similar articles, describing how various systems models can be applied to EMS. These articles will arouse the curiosity of EMS researchers and encourage them to look to these models and others for ways to answer a variety of questions. Spaite has also pointed out that, over time and through osmosis, many of the "standard" therapies del ivered by EMS practitioners have become de facto standards of care, whether they have been scientifically tested or not. 2 It is likely impossible to subject these "standard" treatments to a true randomized controlled trial, because no institutional review board will consider it ethical to withhold the "standard"
AUGUST 1998
32:2
therapy to those patients assigned to the placebo group. We may soon have no choice but to abandon plans to prove or disprove the value of many of these therapies, though studies such as the work by Bickell et al 4 on intravenous fluids in trauma and Gausche's5 work on pediatric intubation give hope that chinks in the traditional armor of untested interventions may be found. We may find it more fruitful. however, to apply some of the models of systems research to examine not just an isolated therapy, but that therapy in the context of the entire EMS system, or better yet the entire medical system itself. Although, as Dr Callaham points out, our citizens generally seem to be willing to continue paying for EMS, it should be noted that voters in Seattle this past November rejected a 6-year, $37-million tax levy to fund Medic One, arguably one of the best and best-studied EMS systems in the world. 6 Maybe our citizenry is wising up and realizing that the EMS emperor is wearing fewer clothes than previously thought. We suggest that systems research has the best chance of properly revealing the state of those clothes, whatever that may be.
David CCone, MD Division of EMS Department of Emergency Medicine MCP-Hahnemann School of Medicine Allegheny University of the Health Sciences Philadelphia, PA Steven J Davidson. MD, MBA Department of Emergency Medicine Maimonides Medical Center SUNY Health Sciences Center-Brooklyn Brooklyn, NY 1. Callaham M: Quantifying the scanty science of prehospital emergency care. Ann Emerg Med 1997;30: 785-790. 2. Spaite DW, Criss EA, Valenzuela rD, et al: Emergency medical services systems research: Problems of the past, challenges of the future. Ann Emerg Med 1995;26:146-152. 3. Maio RF, Spaite D: Using epidemiologic methods to evaluate out-of-hospital care: The ecologiC study. Ann Emerg Med 1995;26:153-157. 4. Bickell WH, Wall Mj, Pepe PE, et al: 1mmediate versus delayed flUid resuscitation for hypotensive patients with penetrating torso injuries. N EnglJ Med 1994;331:1125-1129. 5. Gausche M: A prospective randomized study of the effect of prehospital pediatric intubation on outcome. Arlington, VA: National Center for Education and Maternal and Child Health, 1995. 6. EMS levy rejected. EMS Insider Dec 1997;24(12):5.
ANNALS OF EMERGENCY MEDICINE
In reply: Dr Cone's points about altemative approaches to EMS research are well taken, but I am not nearly as sanguine about their usefulness. Systems research seems to me to be very limited in the information it can provide. It is basically an admission in advance that we understand so little about what is going on, and have such poor data, that we cannot even attempt to perform more accurate analysis. The reader can imagine the limited utility of similar research that considered the entire hospital as a "black box" and only tracked outcomes such as hospital discharge, ignoring all the details of what treatment patients received there. Such research could benchmark an entire hospital as better or worse than others, but it would never pinpoint the reasons for success or failure in a way that would lead to change. The vast majority of EMS systems do not have any form of outcome data that would allow even this type of monitoring or research in its most rudimentary form. Are they getting better? Worse? They don't know. Dr Spaite recommends using the systems model by testing entire systems with methodologically sound and preferably randomized trials of interventions.' This is a different matter altogether than the type of system population research that leads to changing and often contradictory conclusions on the role of fat and other foods in the human diet. for example, and one which is likely to lead to useful information and constructive change. However, the approach recommended by Dr Spaite embraces most of the methodology of traditional clinical trials (and is not particularly easier to implement). The crux of the problem lies not in whether we are using traditional trials or system-based trials, but in the reason why we believe we cannot use the traditional method. Essentially that reason is that we have so little control over the medical care, so little power and influence over the overall EMS system, and such incredibly poor data, that we cannot meet the requirements for responsible investigation. I think that is not much different from saying that we cannot meet the requirements for responsible clinical practice. A similar situation on an inpatient service or a clinic would not be accepted because of the explanation that the environment or the nurses or the residents were "uncontrollable" or "too complex."
273
CORRESPONDENCE Even more worrisome is that a "standard of care" has been determined for us by television shows, the occasional uncritically enthusiastic and usually technophilic physician, paramedics, and fire chiefs, completely unsupported by other than anecdotal evidence. Real control and quality assessment by physicians, so much a principle in every other form of US medical care, is notably absent. So successful has been this setting of the standard by nonmedical means that we now cannot overcome the problem of "unethical" trials of utterly unproven therapies. Perhaps the best place to direct our energies right now would be to develop clear criteria for ethical investigations in EMS, similar to those developed for patients needing emergency resuscitation. These criteria would clarify that decades of traditional usage without evidence of benefit does not constitute a genuine standard of care that it would be unethical to investigate. Dr Cone's letter does remind me to once again thank all the concerned, hard-working paramedics and emergency physicians who do care about quality EMS and who have expressed their support of my suggestions for substantial reform. They reinforce my belief that EMS as a whole is important enough to warrant high standards, traditional forms of proof, and quality research. Enough of the permissive approach. Like an errant teenager (who scores low on the tests but has high selfesteem), what EMS needs now for both its own good and the good of the patients, is tough love.
Michael Callaham, MD Division of Emergency Medicine UCSF Medical Center San Francisco, CA 1. Spaite OW, Criss EA, Valenzuela TO, et al: Emergency medical services systems research: Problems of the past, challenges of the future. Ann Emerg Med 1995;26:146-152.
Tissue Adhesives To the Editor: I have the utmost respect for Dr Richard Edlich and the contributions he has made to the field of wound care, but I am offended by his editorial, "Tissue Adhesives-Revisited."1 As a researcher who spends most of his time on wound care, cosmetic outcomes, and tissue adhesives, I am disappointed that he feels
2 7 4
emergency medicine is "abandoning the care of traumatic lacerations." In contrast to his opinion, wound care research is flourishing in emergency medicine. In the past we depended on basic science models to guide us in the care of wounds. Recently we have started to test these findings with clinical trials to determine the true clinical importance of these models. 2 Our investigations, and work undertaken by Hollander and Singer, are truly the first attempt in any specialty to objectively study clinical outcomes in wound care and they should not be ignored or condemned 3 ,4 Dr Edlich says, " ... emergency physicians •are forced to research other techniques such as adhesive glue," suggesting that we have resorted to some lower standard of care. Tissue adhesives are not a lower standard of care. When tissue adhesives are used properly, they can provide a fast, painless closure with cosmetic outcomes at least as good as traditional suturing. 5 Their properties are preferred by the majority of patients. 6 This is why they have been developed, not because we have "abandoned wound care." No other new wound closure device has undergone as much scrutiny as tissue adhesives. There have been 5 randomized trials on lacerations and 2 on incisions all demonstrating their successful use compared with sutures. 5.7-9 Tissue adhesives cannot replace all sutures, and proper wound care must be followed when they are used for wound closure. Their use requires knowledge and technical skills that should limit their use to knOWledgeable physicians. To suggest my colleagues would support over-the-counter use is an insult to them and anyone who knows anything about these compounds. . Dr Edlich should be aware that the octylcyanoacrylate formulation Dermabond is currently under review by the Food and Drug Administration and has passed all the ISO standards for toxicity and as such is the first cyanoacrylate to be classified as nontoxic.1O Its approval would be the first step to its widespread use as the first nontoxic medical-grade tissue adhesive (other cyanoacrylates were industrial adhesives adapted for medical use). However, we are far from satisfied with this formulation and are continuing to research changes in application techniques, different cyanoacrylate formulations, and a new generation of nontoxic absorbable adhesives that could further revolutionize wound care.
So take comfort, Dr Edlich. Emergency medicine is not abandoning the care of traumatic wounds.
James Quinn, MD Section of Emergency Medicine University of Michigan Ann Arbor, MI 1. Edlich RF: Tissue adhesives-revisited. Ann Emerg Med 1998;31:106-107. 2. Hollander jE, Richman PB, Werblud M, et al: Irrigation
in faCial and scalp lacerations: Does it alter outcome? Ann Emerg Med 1998;31:73-77.
3. Quinn jV, Drzewiecki AE, Stiell IG, et al: Appearance scales to measure cosmetic outcomes of healed lacerations. Am] Emerg Med 1995;13:229-231 . 4. Hollander jE, Singer Aj, Valentine S, et al: Wound registry: Development and validation. Ann Emerg Med 1995; 25:675-685.
5. Quinn jV, Wells GA, Sutcliffe T, et al: A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. ]AMA 1997;227: 1527-1530. 6. Osmond MH, Klassen TP, Quinn jV: Economic comparison of a tissue adhesive and suturing in the repair of pediatric facial lacerations.] Pediatr 1995;126:892-895. 7. Bruns TB, Simon HK, McLario OJ, et al: Laceration repair using a tissue adhesive in a children's emergency department. Pediatrics 1996;98:673-675. 8. Maw jL, QuinnJV, Wells GA, et al: A prospective comparison of octylcyanoacrylate tissue adhesive and sutures for the closure of head and neck incisions. ] Otolaryngol 1997;26:26-30. 9. Kent TM, Bucknall TE: A clinical trial of tissue adhesive in skin closure of groin wounds. Med] Malaysia 1989;44: 122-128.
10. International Standards Organization, Association for Advancement of Medical Instrumentation: Biological Evaluation of Medical Devices, vol 4. Arlington, VA: International Standards Organization, 1995.
In reply: Twenty-five years ago, our laboratory developed the first microporous tape for wound closure. 1The superiority of tape wound closure has been attributed to the resistance to infection of the underlying wound that is greater than wounds containing sutures, staples, or tissue adhesives 2 This unique resistance to infection of tape-closed wounds has been attributed to the absence of the sutural, tissue adhesive, or staple foreign bodies in the wound. These wound closure tapes are ideally suited for closure of wounds subjected to low-static skin tensions. They have been used in an estimated 1 billion patients. The Food and Drug Administration (FDA) has approved their use for wound closure. Tape wound closure is well accepted by children because it can be achieved without discomfort. Despite the advantages
ANNALS OF EMERGENCY MEDICINE
32:2
AUGUST 1998
EMS Research To the Editor: Dr Callaham's excellent article' reviewing the very small number of randomized controlled trials in the EMS literature serves as a notso-gentle reminder that most of the therapies delivered on the streets every day by our EMS systems are unsupported by science. But we believe it is extremely important to recognize that traditional clinical trials may not be the best model for EMS research. Indeed, as Spaite has explained more clearly than we ever could, 2 systems research and not component research must be the future in EMS. It is very difficult to carry the traditional medical research model to the field-so difficult, in fact, that Spaite suggests that inaccurate conclusions are often drawn as a result of inherent limitations in the model and its flawed application to the uncontrolled out-of-hospital environment. Spaite suggests that this component research should be abandoned altogether, in favor of systems research, which draws on multidisciplinary models from such diverse fields as behavioral science, public health, economics, and epidemiology to study entire systems, not just individual components of those systems. Application of these models to EMS will clearly be difficult, since most physicians are not familiar with, never mind formally trained in, these models-yet we must accept Spaite's challenge and take the systems path if we are to prove (or disprove) the value of EMS. The outstanding article by Maio and Spaite 3 on the ecologic study serves as an example of how EMS researchers can adopt and adapt some of these diverse methodologies for the study of out-of-hospital care. What we need now is a flurry of similar articles, describing how various systems models can be applied to EMS. These articles will arouse the curiosity of EMS researchers and encourage them to look to these models and others for ways to answer a variety of questions. Spaite has also pointed out that, over time and through osmosis, many of the "standard" therapies del ivered by EMS practitioners have become de facto standards of care, whether they have been scientifically tested or not. 2 It is likely impossible to subject these "standard" treatments to a true randomized controlled trial, because no institutional review board will consider it ethical to withhold the "standard"
AUGUST 1998
32:2
therapy to those patients assigned to the placebo group. We may soon have no choice but to abandon plans to prove or disprove the value of many of these therapies, though studies such as the work by Bickell et al 4 on intravenous fluids in trauma and Gausche's5 work on pediatric intubation give hope that chinks in the traditional armor of untested interventions may be found. We may find it more fruitful. however, to apply some of the models of systems research to examine not just an isolated therapy, but that therapy in the context of the entire EMS system, or better yet the entire medical system itself. Although, as Dr Callaham points out, our citizens generally seem to be willing to continue paying for EMS, it should be noted that voters in Seattle this past November rejected a 6-year, $37-million tax levy to fund Medic One, arguably one of the best and best-studied EMS systems in the world. 6 Maybe our citizenry is wising up and realizing that the EMS emperor is wearing fewer clothes than previously thought. We suggest that systems research has the best chance of properly revealing the state of those clothes, whatever that may be.
David CCone, MD Division of EMS Department of Emergency Medicine MCP-Hahnemann School of Medicine Allegheny University of the Health Sciences Philadelphia, PA Steven J Davidson. MD, MBA Department of Emergency Medicine Maimonides Medical Center SUNY Health Sciences Center-Brooklyn Brooklyn, NY 1. Callaham M: Quantifying the scanty science of prehospital emergency care. Ann Emerg Med 1997;30: 785-790. 2. Spaite DW, Criss EA, Valenzuela rD, et al: Emergency medical services systems research: Problems of the past, challenges of the future. Ann Emerg Med 1995;26:146-152. 3. Maio RF, Spaite D: Using epidemiologic methods to evaluate out-of-hospital care: The ecologiC study. Ann Emerg Med 1995;26:153-157. 4. Bickell WH, Wall Mj, Pepe PE, et al: 1mmediate versus delayed flUid resuscitation for hypotensive patients with penetrating torso injuries. N EnglJ Med 1994;331:1125-1129. 5. Gausche M: A prospective randomized study of the effect of prehospital pediatric intubation on outcome. Arlington, VA: National Center for Education and Maternal and Child Health, 1995. 6. EMS levy rejected. EMS Insider Dec 1997;24(12):5.
ANNALS OF EMERGENCY MEDICINE
In reply: Dr Cone's points about altemative approaches to EMS research are well taken, but I am not nearly as sanguine about their usefulness. Systems research seems to me to be very limited in the information it can provide. It is basically an admission in advance that we understand so little about what is going on, and have such poor data, that we cannot even attempt to perform more accurate analysis. The reader can imagine the limited utility of similar research that considered the entire hospital as a "black box" and only tracked outcomes such as hospital discharge, ignoring all the details of what treatment patients received there. Such research could benchmark an entire hospital as better or worse than others, but it would never pinpoint the reasons for success or failure in a way that would lead to change. The vast majority of EMS systems do not have any form of outcome data that would allow even this type of monitoring or research in its most rudimentary form. Are they getting better? Worse? They don't know. Dr Spaite recommends using the systems model by testing entire systems with methodologically sound and preferably randomized trials of interventions.' This is a different matter altogether than the type of system population research that leads to changing and often contradictory conclusions on the role of fat and other foods in the human diet. for example, and one which is likely to lead to useful information and constructive change. However, the approach recommended by Dr Spaite embraces most of the methodology of traditional clinical trials (and is not particularly easier to implement). The crux of the problem lies not in whether we are using traditional trials or system-based trials, but in the reason why we believe we cannot use the traditional method. Essentially that reason is that we have so little control over the medical care, so little power and influence over the overall EMS system, and such incredibly poor data, that we cannot meet the requirements for responsible investigation. I think that is not much different from saying that we cannot meet the requirements for responsible clinical practice. A similar situation on an inpatient service or a clinic would not be accepted because of the explanation that the environment or the nurses or the residents were "uncontrollable" or "too complex."
273
CORRESPONDENCE Even more worrisome is that a "standard of care" has been determined for us by television shows, the occasional uncritically enthusiastic and usually technophilic physician, paramedics, and fire chiefs, completely unsupported by other than anecdotal evidence. Real control and quality assessment by physicians, so much a principle in every other form of US medical care, is notably absent. So successful has been this setting of the standard by nonmedical means that we now cannot overcome the problem of "unethical" trials of utterly unproven therapies. Perhaps the best place to direct our energies right now would be to develop clear criteria for ethical investigations in EMS, similar to those developed for patients needing emergency resuscitation. These criteria would clarify that decades of traditional usage without evidence of benefit does not constitute a genuine standard of care that it would be unethical to investigate. Dr Cone's letter does remind me to once again thank all the concerned, hard-working paramedics and emergency physicians who do care about quality EMS and who have expressed their support of my suggestions for substantial reform. They reinforce my belief that EMS as a whole is important enough to warrant high standards, traditional forms of proof, and quality research. Enough of the permissive approach. Like an errant teenager (who scores low on the tests but has high selfesteem), what EMS needs now for both its own good and the good of the patients, is tough love.
Michael Callaham, MD Division of Emergency Medicine UCSF Medical Center San Francisco, CA 1. Spaite OW, Criss EA, Valenzuela TO, et al: Emergency medical services systems research: Problems of the past, challenges of the future. Ann Emerg Med 1995;26:146-152.
Tissue Adhesives To the Editor: I have the utmost respect for Dr Richard Edlich and the contributions he has made to the field of wound care, but I am offended by his editorial, "Tissue Adhesives-Revisited."1 As a researcher who spends most of his time on wound care, cosmetic outcomes, and tissue adhesives, I am disappointed that he feels
2 7 4
emergency medicine is "abandoning the care of traumatic lacerations." In contrast to his opinion, wound care research is flourishing in emergency medicine. In the past we depended on basic science models to guide us in the care of wounds. Recently we have started to test these findings with clinical trials to determine the true clinical importance of these models. 2 Our investigations, and work undertaken by Hollander and Singer, are truly the first attempt in any specialty to objectively study clinical outcomes in wound care and they should not be ignored or condemned 3 ,4 Dr Edlich says, " ... emergency physicians •are forced to research other techniques such as adhesive glue," suggesting that we have resorted to some lower standard of care. Tissue adhesives are not a lower standard of care. When tissue adhesives are used properly, they can provide a fast, painless closure with cosmetic outcomes at least as good as traditional suturing. 5 Their properties are preferred by the majority of patients. 6 This is why they have been developed, not because we have "abandoned wound care." No other new wound closure device has undergone as much scrutiny as tissue adhesives. There have been 5 randomized trials on lacerations and 2 on incisions all demonstrating their successful use compared with sutures. 5.7-9 Tissue adhesives cannot replace all sutures, and proper wound care must be followed when they are used for wound closure. Their use requires knowledge and technical skills that should limit their use to knOWledgeable physicians. To suggest my colleagues would support over-the-counter use is an insult to them and anyone who knows anything about these compounds. . Dr Edlich should be aware that the octylcyanoacrylate formulation Dermabond is currently under review by the Food and Drug Administration and has passed all the ISO standards for toxicity and as such is the first cyanoacrylate to be classified as nontoxic.1O Its approval would be the first step to its widespread use as the first nontoxic medical-grade tissue adhesive (other cyanoacrylates were industrial adhesives adapted for medical use). However, we are far from satisfied with this formulation and are continuing to research changes in application techniques, different cyanoacrylate formulations, and a new generation of nontoxic absorbable adhesives that could further revolutionize wound care.
So take comfort, Dr Edlich. Emergency medicine is not abandoning the care of traumatic wounds.
James Quinn, MD Section of Emergency Medicine University of Michigan Ann Arbor, MI 1. Edlich RF: Tissue adhesives-revisited. Ann Emerg Med 1998;31:106-107. 2. Hollander jE, Richman PB, Werblud M, et al: Irrigation
in faCial and scalp lacerations: Does it alter outcome? Ann Emerg Med 1998;31:73-77.
3. Quinn jV, Drzewiecki AE, Stiell IG, et al: Appearance scales to measure cosmetic outcomes of healed lacerations. Am] Emerg Med 1995;13:229-231 . 4. Hollander jE, Singer Aj, Valentine S, et al: Wound registry: Development and validation. Ann Emerg Med 1995; 25:675-685.
5. Quinn jV, Wells GA, Sutcliffe T, et al: A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. ]AMA 1997;227: 1527-1530. 6. Osmond MH, Klassen TP, Quinn jV: Economic comparison of a tissue adhesive and suturing in the repair of pediatric facial lacerations.] Pediatr 1995;126:892-895. 7. Bruns TB, Simon HK, McLario OJ, et al: Laceration repair using a tissue adhesive in a children's emergency department. Pediatrics 1996;98:673-675. 8. Maw jL, QuinnJV, Wells GA, et al: A prospective comparison of octylcyanoacrylate tissue adhesive and sutures for the closure of head and neck incisions. ] Otolaryngol 1997;26:26-30. 9. Kent TM, Bucknall TE: A clinical trial of tissue adhesive in skin closure of groin wounds. Med] Malaysia 1989;44: 122-128.
10. International Standards Organization, Association for Advancement of Medical Instrumentation: Biological Evaluation of Medical Devices, vol 4. Arlington, VA: International Standards Organization, 1995.
In reply: Twenty-five years ago, our laboratory developed the first microporous tape for wound closure. 1The superiority of tape wound closure has been attributed to the resistance to infection of the underlying wound that is greater than wounds containing sutures, staples, or tissue adhesives 2 This unique resistance to infection of tape-closed wounds has been attributed to the absence of the sutural, tissue adhesive, or staple foreign bodies in the wound. These wound closure tapes are ideally suited for closure of wounds subjected to low-static skin tensions. They have been used in an estimated 1 billion patients. The Food and Drug Administration (FDA) has approved their use for wound closure. Tape wound closure is well accepted by children because it can be achieved without discomfort. Despite the advantages
ANNALS OF EMERGENCY MEDICINE
32:2
AUGUST 1998