Opinions expressed in the Correspondence section are those of the authors, and not necessarily of the editors, ACER or SAEM. The editor reserves the right to edit and publish letters as space permits. Letters not meeting submission criteria will not be considered for publication. See "Information for Authors."
CORRESPONDENCE Questions & Answers: Statistical Tests & Consent To the Editor: The article by Aufderheide et al, "The Diagnostic Impact of Prehospital 12-Lead E l e c t r o c a r d i o g r a p h y " [November 1990;19:1280-1287], presents a large amount of data about the accuracy of paramedic clinical diagnosis using ECG telemetry. The result section is filled with P values and phrases such as "a significant number of patients," and yet there is absolutely no indication how these data were analyzed. In the methods section, the m e t h o d o l o g y of the study is well defined, but there is no indication of the statistical tests used to obtain the P values. In order to reject the null hypothesis and accept an experimental hypothesis, rigorous statistical tests must be performed. The statistical methodology is a critical part of any paper; it is therefore difficult for me to understand how it could simply be omitted by both the authors and overlooked by the reviewers. I would also be curious to know from the authors what type of consent process was used for this research study. The a g r e e m e n t between medical personnel and patients to participate in a research study is a very important process for ensuring protection of patients and quality medical research. I would be curious to know if the paramedics were formally instructed on how to obtain consent that would include listing the risks and benefits of such a process and whether they documented the consent process. This is a very important aspect of prehospital research that I think is all too often overlooked.
William H Spivey, MD, FACEP Division of Research Department of Emergency Medicine Medical College of Pennsylvania Philadelphia
In Reply: I t h a n k Dr Spivey for his comments regarding statistical tests and the consent process for our manu20:12 December 1991
script. He correctly points out our omission of the statistical tests used to obtain P values. Data were analyzed by data-one, Fisher's exact test, and Student's t test where appropriate. P values were considered significant at < .05. Our emergency medical services system has a policy of using a verbal consent process in all prehospital research. For this study in 1988, param e d i c s were i n s e r v i c e d and instructed to inform the patient that prehospital ECG machines were being field tested; that the information from them could not be used in their treatment, but would be used for research purposes to determine the value of these machines later; and to obtain verbalized agreement from the patient before proceeding with 12lead ECG acquisition. Standardized verbal informed consent was not used for this project. The Human Research Review C o m m i t t e e of the Medical College of Wisconsin reviewed and approved this initial approach.
R o b e r t J Rothstein, MD, FACEP - Section Editor Bethesda, Maryland
When presenting our initial findings at an investigators' meeting, the verbal c o n s e n t process was discussed. As a result of this collaboration, all subsequent prehospital ECG studies have used standardized verbal informed consent in which a written consent statement is secured to the inside lid of the ECG machine and read verbatim by the paramedic. The s t a t e m e n t identifies the research study, describes any procedures, and identifies p o t e n t i a l benefits and risks. Prehospital 12-lead electrocardiography has the potential benefit of improved care. Review of our initial data and collaboration of other investigators revealed that prehospital ECG acquisition may prolong scene time and represent the potential risk of delay to hospital arrival in a possibly ischemic patient. For this reason, we have included this potential risk Annals of Emergency Medicine
in all subsequent consent processes. We agree with the importance of standardized verbal consent in ensuring comprehensive and uniform delivery of i n f o r m a t i o n to potential study subjects.
Tom P Aufderheide, MD Emergency Medicine Medical College of Wisconsin Milwaukee
Preventing Prescription Fraud To the Editor: While the problem of fraudulent prescription requesting is seemingly on the rise, t it remains largely undiscussed in the emergency medicine literature. Several years ago we noted that emergency department patients presenting for prescription refills frequently requested certain medications not thought to have significant abuse potential: H2 blockers, nonsteroidal anti-inflammatory agents, and inhaled bronchodilators. Moreover, these individuals generally gave similar stories: their prescriptions had either been stolen or lost in a fire. Recently, such medication requests have included zidovudine, lovastatin, and clonidine. We have long suspected that the patients in question were using their Medicaid cards to obtain expensive medications, which they would then sell back to dishonest pharmacists. A recent local news broadcast 2 confirmed the existence of such practices. We also have speculated that these medications are being used to treat untoward side effects of illicit drugs or alcohol or to potentiate the desired action of these substances. Clonidine, for example, is effective in the management of alcohol and opiate withdrawal. ,3 H2 blockers have been s h o w n to increase the bioavailability of ethanol, meperidine, and possibly methadone. 4-6 We strongly urge Medicaid and other regulatory agencies that monitor use of prescription drugs to investigate these claims and apprehend the principal offenders. Meanwhile, it is important that emergency physicians and nurses be aware of this 1396/159
CORRESPONDENCE Questions & Answers: Statistical Tests & Consent To the Editor: The article by Aufderheide et al, "The Diagnostic Impact of Prehospital 12-Lead E l e c t r o c a r d i o g r a p h y " [November 1990;19:1280-1287], presents a large amount of data about the accuracy of paramedic clinical diagnosis using ECG telemetry. The result section is filled with P values and phrases such as "a significant number of patients," and yet there is absolutely no indication how these data were analyzed. In the methods section, the m e t h o d o l o g y of the study is well defined, but there is no indication of the statistical tests used to obtain the P values. In order to reject the null hypothesis and accept an experimental hypothesis, rigorous statistical tests must be performed. The statistical methodology is a critical part of any paper; it is therefore difficult for me to understand how it could simply be omitted by both the authors and overlooked by the reviewers. I would also be curious to know from the authors what type of consent process was used for this research study. The a g r e e m e n t between medical personnel and patients to participate in a research study is a very important process for ensuring protection of patients and quality medical research. I would be curious to know if the paramedics were formally instructed on how to obtain consent that would include listing the risks and benefits of such a process and whether they documented the consent process. This is a very important aspect of prehospital research that I think is all too often overlooked.
William H Spivey, MD, FACEP Division of Research Department of Emergency Medicine Medical College of Pennsylvania Philadelphia
In Reply: I t h a n k Dr Spivey for his comments regarding statistical tests and the consent process for our manu20:12 December 1991
script. He correctly points out our omission of the statistical tests used to obtain P values. Data were analyzed by data-one, Fisher's exact test, and Student's t test where appropriate. P values were considered significant at < .05. Our emergency medical services system has a policy of using a verbal consent process in all prehospital research. For this study in 1988, param e d i c s were i n s e r v i c e d and instructed to inform the patient that prehospital ECG machines were being field tested; that the information from them could not be used in their treatment, but would be used for research purposes to determine the value of these machines later; and to obtain verbalized agreement from the patient before proceeding with 12lead ECG acquisition. Standardized verbal informed consent was not used for this project. The Human Research Review C o m m i t t e e of the Medical College of Wisconsin reviewed and approved this initial approach.
R o b e r t J Rothstein, MD, FACEP - Section Editor Bethesda, Maryland
When presenting our initial findings at an investigators' meeting, the verbal c o n s e n t process was discussed. As a result of this collaboration, all subsequent prehospital ECG studies have used standardized verbal informed consent in which a written consent statement is secured to the inside lid of the ECG machine and read verbatim by the paramedic. The s t a t e m e n t identifies the research study, describes any procedures, and identifies p o t e n t i a l benefits and risks. Prehospital 12-lead electrocardiography has the potential benefit of improved care. Review of our initial data and collaboration of other investigators revealed that prehospital ECG acquisition may prolong scene time and represent the potential risk of delay to hospital arrival in a possibly ischemic patient. For this reason, we have included this potential risk Annals of Emergency Medicine
in all subsequent consent processes. We agree with the importance of standardized verbal consent in ensuring comprehensive and uniform delivery of i n f o r m a t i o n to potential study subjects.
Tom P Aufderheide, MD Emergency Medicine Medical College of Wisconsin Milwaukee
Preventing Prescription Fraud To the Editor: While the problem of fraudulent prescription requesting is seemingly on the rise, t it remains largely undiscussed in the emergency medicine literature. Several years ago we noted that emergency department patients presenting for prescription refills frequently requested certain medications not thought to have significant abuse potential: H2 blockers, nonsteroidal anti-inflammatory agents, and inhaled bronchodilators. Moreover, these individuals generally gave similar stories: their prescriptions had either been stolen or lost in a fire. Recently, such medication requests have included zidovudine, lovastatin, and clonidine. We have long suspected that the patients in question were using their Medicaid cards to obtain expensive medications, which they would then sell back to dishonest pharmacists. A recent local news broadcast 2 confirmed the existence of such practices. We also have speculated that these medications are being used to treat untoward side effects of illicit drugs or alcohol or to potentiate the desired action of these substances. Clonidine, for example, is effective in the management of alcohol and opiate withdrawal. ,3 H2 blockers have been s h o w n to increase the bioavailability of ethanol, meperidine, and possibly methadone. 4-6 We strongly urge Medicaid and other regulatory agencies that monitor use of prescription drugs to investigate these claims and apprehend the principal offenders. Meanwhile, it is important that emergency physicians and nurses be aware of this 1396/159
