Editorials
to Setting up, obtaining the patient's Perception, obtaining the patient's Invitation, giving Knowledge and information to the patient, addressing the patient's Emotions with Empathetic responses, and Strategy and Summary. Pre- and postquestionnaires demonstrated significant improvement of all 21 survey items evaluating staff satisfaction with family conferences. Three of seven survey items evaluating family satisfaction with communication were significantly improved. Both the quantity and quality of family care conferences matter. Patient- and family-centered care has become a widely touted and promoted care model (6). However, it has yet to become the standard of care. We should all be wondering why. Isn't our role to care for ICU patients in accordance with their wishes? Can we do that without incorporating information that, in many cases, only family can provide? Can we in good conscience neglect attending to the needs of the patient's often obviously suffering family members? How would the patient view this behavior? Family bedside presence and participation in care can be of great comfort to the patient and a valuable resource to the team during the ICU stay. In addition, both patients and families are at risk for postintensive care syndrome (7, 8). The immediate family is often impacted by the patient's critical illness for months or years postdischarge. They could be caring for the patient long after they leave our unit. The better the family communication and care in the ICU, the less severe the postdischarge consequences for both patients and families may be. If we give the family the proper care and attention in the ICU, they are more likely to be able to give it to the patient at home.
The family is our link to the patient's past, a resource during their ICU stay, and a bridge to the patient's future health status. With good communication, we can make a bigger difference in the present and future well-being of our patients and their families. Improving family care conferences is just one part of making a unit an intensive caring unit as well as an ICU.
REFERENCES 1. Davidson JE, Powers K, Hedayat KM, et al: Glinical practice guidelines for support of the family in the patient-centered intensive care unit: American Gollege of Gritical Gare Medioine Task Force 20042005. Crit Care Med 2007; 35:605-622 2. Krimshtein NS, Luhrs GA, Puntillo KA, et al: Training nurses tor interdisciplinary communication with families in the intensive care unit: An intervention. J Palliât Med 2011 ; 14:1325-1332 3. Gurtis JR, Giechanowski PS, Downey L, et al: Development and evaluation of an interprofessional communication intervention to improve family outcomes in the IGU. Contemp Clin Trials 2012; 33:1245-1254 4. Scheunemann LP, McDevitt M, Garson SS, et al: Randomized controlled trials on interventions to improve communication in intensive care: A systematic review. Chest 2011 ; 139:543-554 5. Shaw DJ, Davidson JE, Smilde Rl, etal: Multidisciplinary Team Training to Enhance Family Gommunication in the IGU. Crit Care Med 2014; 42:265-271 6. Institute tor Patient- and Family-Gentered Gare: Available at: http:// www.ipfcc.org. Accessed August 13, 2013 7. Needham DM, Davidson J, Gohen H, et al: Improving long-term outcomes after discharge from intensive care unit: Report trom a stakeholders' conference. Crit Care Med 201 2; 40:502-509 8. Davidson JE, Jones G, Bienvenu GJ: Family response to critical illness: Postintensive care syndrome-family. Crit Care Med 201 2; 40:618-624
Studying Community Consultation in Exception From Informed Consent Trials* Clifton W. Callaway, MD, PhD Department of Emergency Medicine University of Pittsburgh Pittsburgh, PA
*See also p. 272. Key Words: ethics; informed consent; resuscitation; traumatic brain injury Dr. Gallaway received support tor article research trom the National Institutes ot Health. Dr. Gallaway's institution received grant support from the National Heart, Lung, and Blood Institute (5K12HL109068 and U01 HL077871) and the National Institute of Neurological Disorders and Stroke (U10 NS08037t). Dr. Gallaway is a site investigator tor the Neurological Emergencies Treatment Trial network and the Resuscitation Gutcomes Gonsortium. The content is solely the responsibility ot the author and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Gopyright © 201 3 by the Society ot Gritical Gare Medioine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0b013e3182a51f37
Critical Care Medicine
ome readers may not remember a crisis 20 years ago ^ when a moratorium on emergency care research was pronounced in the United States ( 1 ). Federal regulatory bodies reviewed the practice of enrolling unconscious patients into clinical research without informed consent using various justifications, such as "deferred consent," "impHed consent," and "retrospective consent" (2). These justifications were deemed to conflict with the principle of subject autonomy as set out in the Declaration of Helsinki and the Nuremberg Code (3, 4). Ongoing trials were halted, and institutional review boards (IRBs) were directed to approve no new trials of more than minimal risk without prospective consent (5). The moratorium decreased the number of trials on resuscitation from the United States for at least a decade relative to trials in other diseases (6, 7). Other countries subsequently developed regulatory angst over emergency care research (8). Many young investigators doing clinical resuscitation science left the field during the moratorium to develop careers studying other conditions that allowed more traditional informed www.ccmjournai.org
451
Editorials
consent. One wonders what would be the state of clinical resuscitation science today had the moratorium never occurred. Dedicated scientists, including Dickert et al (9) who are the authors of a study presented in this issue of Critical Care Medicine, worked with federal regulators to develop our current framework for conducting acute care research: exception from informed consent (EFIC) in emergency situations. EFIC was announced in 1996 along with guidance for IRBs and investigators (10). Among the multiple criteria for use of EFIC, the hallmark requirement is notification and consultation with the communities in which research will be conducted. Although more burdensome than the prior doctrines, EFIC does provide a well-vetted regulatory basis for conducting acute care research. Finally, after 20 years, the pace of clinical resuscitation and emergency care research has resumed the upward trajectory it enjoyed in the early 1990s. Community consultation serves many functions in EFIC. Most importantly, consultation provides community members with representative autonomy to accept or reject participation. In an ideal situation, every community member would hear about and consent to potential participation in a trial prior to that trial commencing. In practice, the consultation process needs to achieve at least a meaningful, representative sample whose opinions reflect those of the actual subjects who are enrolled. There is a paucity of research comparing the validity of different consultation techniques for EFIC (11). This research is essential for investigators to keep pace with society. Past trials with EFIC used consultation techniques suggested by the original guidance: focus groups, community meetings, advertisements with call-in numbers, and so forth. However, the world has changed dramatically since the writing of the guidance. In 1993, the World Wide Web was new, there were more landlines than cell phones, there was no social media, and text messaging was just invented. Patients did not search the Internet to learn about their disease or treatment options. Today, these asynchronous modalities for dissemination of information and measurement of public opinion are more the norm than townhall meetings. Some groups have called for a greater measure of judgment in choosing to use any or all of these techniques to interact with communities (12). In the present study, investigators embedded a study about community consultation within the approval process for a trial of progesterone for traumatic brain injury to be conducted with EFIC (http://www.clinicaltrials.gov: NCT00822900). Importantly, this study compares the responses that are generated when interactive methods (e.g., in-person meetings with an investigator presentation) or less interactive methods (e.g., surveys handed out) are used for community consultation. This study notes that public opinion in some individual events was not in favor of EFIC in general or even of personal enrollment in this trial in particular. Nevertheless, the overall average of responses favors EFIC and personal enrollment in the trial. This clinical trial is now ongoing even in the communities that had strong negative responses. Such an approach is consistent with a purely democratic philosophy: majority 452
www.ccmjournal.org
opinion decides the fate of the community. However, it may be worth further philosophical and ethical debate on this conclusion. Should more protection be provided for members of the community with minority opinions? That approach would be consistent with the protectionist stance toward minorities that we adopt in other aspects of public life. Another function of community consultation is allowing the investigator to share responsibility with the community for subjects who are hurt in a trial or who are upset after the trial. Adverse outcomes are much easier to defend and accept for situations and risks that "everyone knew about" and "most people thought were a good idea." The validity of this function requires that risks were adequately disclosed to the community participants. This study reports that participants perceive risk differently when presented in different formats. Participants in more interactive settings minimized their estimates of study risk compared with participants in less interactive settings. Although this study cannot determine exactly why this difference in perception occurred, it is easy to speculate that investigator enthusiasm or nonverbal cues about risk-benefit profiles influenced participants in interactive sessions. These differences in risk perception are important because past critiques of public consultation in EFIC trials focused primarily on whether risks were adequately disclosed (13). The present data might suggest that less interactive methods are a more conservative estimate of public opinion and might be preferred for providing fair assessment of risk. We must continue collecting rigorous data about community consultation and other aspects of EFIC. Progress in acute care research depends on having a solid and contemporary ethical basis for conducting research on vulnerable patients who cannot consent for themselves. The present study provides an excellent example of how investigative teams can study and make specific meaningful conclusions about these practices. Similar studies should be embedded in all trials employing EFIC.
REFERENCES 1. CIson CM: The letter or fhe spirit. Consent for research in CPR. JAMA 1994; 271:1445-1447 2. Abramson NS, Meisel A, Safar P: Deferred eonsenf. A new approach for resuscitation research on comatose pafienfs. JAMA 1986; 255:2466-2471 3. Kafz J: The Nuremberg Code and the Nuremberg Trial. A reappraisal. JAMA 1996; 276:1662-1666 4. Rickham PP: Human experimentation. Code of efhics of fhe world medical associafion. Deelarafion of Helsinki. Br Med J 1964; 2:177 5. Ellis GB: OPRR Reports: Informed Consenf-Legally Effecfive and Prospeotively Obtained. Augusf 12, 1993. Available af: http://www. hhs.gov/ohrp/policy/hsdc93-03.hfml. Accessed Augusf 13, 2013 6. Nichol G, Huszti E, Rokosh J, etal: Impact of informed consent requirements on cardiac arrest research in the Unifed Sfafes: Exception from consent or from research? Resuscitation 2004; 62:3-23 7 Hiller KM, Haukoos JS, Heard K, ef al: Impacf of fhe Final Rule on fhe rafe of clinical cardiac arresf research in the Unifed Sfafes. Aead Emerg Med 2005; 12:1091-1098 8. Sferz F, A Singer E, Böffiger B, et al: A serious threat fo evidence based resuscifation within fhe European Union. Resuseitation 2002; 53:237-238 9. Dickerf NW, Mah VA, Biros MH, ef al: Consulfing Communifies When Patients Cannot Consent: A Mulficenter Study of Community February 201 4 • Volume 42 • Number 2
Editorials Consultation for Research in Emergency Settings. Crit Care Med 2014; 42:272-280 10. 21CFR50.24-Code of Federal Regulations Title 21: Part 50. Protection of Human Subjects. Section 50.24. Exception from informed consent requirements for emergency research. October 2, 1996; Revised April 1,2013 11. Baren JM, Biros MH: The research on community consultation: An annotated bibliography. Acad Emerg Med 2007; 14:346-352 12. Halperin H, Paradis N, Mosesso V Jr, et al; American Heart Association Emergency Cardiovascular Care Committee; American
Heart Association Council on Cardiopulmonary, Perioperative and Critical Care: Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's "Exception from informed consent requirements for emergency research": A special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: Endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine. Circulation 2007; 116:1855-1863 13. Grassley C: Americans should not be on a game show in U.S. emergency rooms and ambulances. Am J Bioeth 2010; 10:9-10
Outcomes in Elderly Patients Resuscitated From Cardiac Arrest: Is Age an Independent Predictor?' Ciaudio Sandroni, MD Anseimo Caricato, MD Department of Anaesthesiology and Intensive Care Catholic University School of Medicine Rome, Italy
M
ortality after cardiac arrest is high. Less than 20% of patients resuscitated from in-hospital cardiac arrest (IHCA) survive to hospital discharge (1). Advancing age is associated with worse outcomes after critical illness (2), and cardiac arrest make no exception. Survival to discharge after IHCA consistently decreases by 2% every 5 years of age above 65 (3), and according to recent evidence (4), less than 10% of IHCA victims above 65 years are alive at 1 year. However, the nature of the association between age and survival after cardiopulmonary resuscitation (CPR) is debated. Although some investigators reported that increasing age is an independent factor for mortality after cardiac arrest (5), others did not (6). In general, age seems to be less important in determining final outcome than event variables, like initial cardiac rhythm, witnessed status, or the interval between cardiac arrest and resuscitation interventions (7). Furthermore, separating the effect on outcome of age from that of comorbidities which are naturally associated with ageing is difficult. Finally, the lower survival rates observed in older victims of cardiac arrest may be due to a higher prevalence of withdrawal of life-sustaining therapies (WLST) due to perception of poor long-term outcome in this category of patients (8).
'See also p. 289. Key Words: aged; do-not-resuscitate order; outcome; prognostication; resuscitation The authors have disclosed that they do not have any potential conflicts of interest. Copyright © 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0b013e3182a52192
Critical Care Medicine
In this issue of Critical Care Medicine, Seder et al (9) present the results of a retrospective evaluation of recent registry data from six regional percutaneous coronary intervention centers in the United States. They compared the rates of survival and good neurological outcome (Cerebral Performance Categories 1 or 2) of 129 unresponsive cardiac arrest survivors older than 75 years with those of 625 patients 18-75 years old. Patients were matched for presenting rhythm, witnessed status, bystander CPR, and total ischémie time. On univariate analysis, resuscitated patients older than 75 years were less likely to survive to hospital discharge (33% vs 46%, p = 0.009) and to survive with good neurological outcome at 6 months (26.4% vs 40.5%, p = 0.003) than younger patients. However, they were also more likely to have do-not-resuscitate (DNR) orders (65.9% vs 48.2%, p < 0.001) and to undergo WLST (61.2% vs 47.5%, p - 0.005). Age more than 75 years was independently associated with poor outcome, but this association disappeared when DNR status was added to a multivariate logistic regression analysis model. Among variables included in the model, presence of DNR had the highest odds ratio for poor neurological outcome. Seder et al (9) did not report the reasons for which the DNR orders were made. These may have included the presence of other comorbidities not considered in the study model. Another reason could have been a diagnosis of severe hypoxicischemic brain damage (all patients were unresponsive at study inception). Prediction of a poor neurological outcome, usually based on a series of clinical or electrophysiological tests, is a major reason for WLST (10). Unfortunately, most of these predictors have recently been demonstrated to be much less accurate than previously believed (11, 12). In the study by Seder et al (9), among 385 patients for whom a DNR order was placed, 28 survived to hospital discharge and nine had good outcome at 6-month follow-up, which suggests that the attitude of the treating teams toward resuscitated patients may have been exaggeratedly pessimistic in some cases. Another reason for prescribing DNR could have been the perception of a short length or poor quality of future life. www.ccr-njournaLorg
453
Copyright of Critical Care Medicine is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
to Setting up, obtaining the patient's Perception, obtaining the patient's Invitation, giving Knowledge and information to the patient, addressing the patient's Emotions with Empathetic responses, and Strategy and Summary. Pre- and postquestionnaires demonstrated significant improvement of all 21 survey items evaluating staff satisfaction with family conferences. Three of seven survey items evaluating family satisfaction with communication were significantly improved. Both the quantity and quality of family care conferences matter. Patient- and family-centered care has become a widely touted and promoted care model (6). However, it has yet to become the standard of care. We should all be wondering why. Isn't our role to care for ICU patients in accordance with their wishes? Can we do that without incorporating information that, in many cases, only family can provide? Can we in good conscience neglect attending to the needs of the patient's often obviously suffering family members? How would the patient view this behavior? Family bedside presence and participation in care can be of great comfort to the patient and a valuable resource to the team during the ICU stay. In addition, both patients and families are at risk for postintensive care syndrome (7, 8). The immediate family is often impacted by the patient's critical illness for months or years postdischarge. They could be caring for the patient long after they leave our unit. The better the family communication and care in the ICU, the less severe the postdischarge consequences for both patients and families may be. If we give the family the proper care and attention in the ICU, they are more likely to be able to give it to the patient at home.
The family is our link to the patient's past, a resource during their ICU stay, and a bridge to the patient's future health status. With good communication, we can make a bigger difference in the present and future well-being of our patients and their families. Improving family care conferences is just one part of making a unit an intensive caring unit as well as an ICU.
REFERENCES 1. Davidson JE, Powers K, Hedayat KM, et al: Glinical practice guidelines for support of the family in the patient-centered intensive care unit: American Gollege of Gritical Gare Medioine Task Force 20042005. Crit Care Med 2007; 35:605-622 2. Krimshtein NS, Luhrs GA, Puntillo KA, et al: Training nurses tor interdisciplinary communication with families in the intensive care unit: An intervention. J Palliât Med 2011 ; 14:1325-1332 3. Gurtis JR, Giechanowski PS, Downey L, et al: Development and evaluation of an interprofessional communication intervention to improve family outcomes in the IGU. Contemp Clin Trials 2012; 33:1245-1254 4. Scheunemann LP, McDevitt M, Garson SS, et al: Randomized controlled trials on interventions to improve communication in intensive care: A systematic review. Chest 2011 ; 139:543-554 5. Shaw DJ, Davidson JE, Smilde Rl, etal: Multidisciplinary Team Training to Enhance Family Gommunication in the IGU. Crit Care Med 2014; 42:265-271 6. Institute tor Patient- and Family-Gentered Gare: Available at: http:// www.ipfcc.org. Accessed August 13, 2013 7. Needham DM, Davidson J, Gohen H, et al: Improving long-term outcomes after discharge from intensive care unit: Report trom a stakeholders' conference. Crit Care Med 201 2; 40:502-509 8. Davidson JE, Jones G, Bienvenu GJ: Family response to critical illness: Postintensive care syndrome-family. Crit Care Med 201 2; 40:618-624
Studying Community Consultation in Exception From Informed Consent Trials* Clifton W. Callaway, MD, PhD Department of Emergency Medicine University of Pittsburgh Pittsburgh, PA
*See also p. 272. Key Words: ethics; informed consent; resuscitation; traumatic brain injury Dr. Gallaway received support tor article research trom the National Institutes ot Health. Dr. Gallaway's institution received grant support from the National Heart, Lung, and Blood Institute (5K12HL109068 and U01 HL077871) and the National Institute of Neurological Disorders and Stroke (U10 NS08037t). Dr. Gallaway is a site investigator tor the Neurological Emergencies Treatment Trial network and the Resuscitation Gutcomes Gonsortium. The content is solely the responsibility ot the author and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Gopyright © 201 3 by the Society ot Gritical Gare Medioine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0b013e3182a51f37
Critical Care Medicine
ome readers may not remember a crisis 20 years ago ^ when a moratorium on emergency care research was pronounced in the United States ( 1 ). Federal regulatory bodies reviewed the practice of enrolling unconscious patients into clinical research without informed consent using various justifications, such as "deferred consent," "impHed consent," and "retrospective consent" (2). These justifications were deemed to conflict with the principle of subject autonomy as set out in the Declaration of Helsinki and the Nuremberg Code (3, 4). Ongoing trials were halted, and institutional review boards (IRBs) were directed to approve no new trials of more than minimal risk without prospective consent (5). The moratorium decreased the number of trials on resuscitation from the United States for at least a decade relative to trials in other diseases (6, 7). Other countries subsequently developed regulatory angst over emergency care research (8). Many young investigators doing clinical resuscitation science left the field during the moratorium to develop careers studying other conditions that allowed more traditional informed www.ccmjournai.org
451
Editorials
consent. One wonders what would be the state of clinical resuscitation science today had the moratorium never occurred. Dedicated scientists, including Dickert et al (9) who are the authors of a study presented in this issue of Critical Care Medicine, worked with federal regulators to develop our current framework for conducting acute care research: exception from informed consent (EFIC) in emergency situations. EFIC was announced in 1996 along with guidance for IRBs and investigators (10). Among the multiple criteria for use of EFIC, the hallmark requirement is notification and consultation with the communities in which research will be conducted. Although more burdensome than the prior doctrines, EFIC does provide a well-vetted regulatory basis for conducting acute care research. Finally, after 20 years, the pace of clinical resuscitation and emergency care research has resumed the upward trajectory it enjoyed in the early 1990s. Community consultation serves many functions in EFIC. Most importantly, consultation provides community members with representative autonomy to accept or reject participation. In an ideal situation, every community member would hear about and consent to potential participation in a trial prior to that trial commencing. In practice, the consultation process needs to achieve at least a meaningful, representative sample whose opinions reflect those of the actual subjects who are enrolled. There is a paucity of research comparing the validity of different consultation techniques for EFIC (11). This research is essential for investigators to keep pace with society. Past trials with EFIC used consultation techniques suggested by the original guidance: focus groups, community meetings, advertisements with call-in numbers, and so forth. However, the world has changed dramatically since the writing of the guidance. In 1993, the World Wide Web was new, there were more landlines than cell phones, there was no social media, and text messaging was just invented. Patients did not search the Internet to learn about their disease or treatment options. Today, these asynchronous modalities for dissemination of information and measurement of public opinion are more the norm than townhall meetings. Some groups have called for a greater measure of judgment in choosing to use any or all of these techniques to interact with communities (12). In the present study, investigators embedded a study about community consultation within the approval process for a trial of progesterone for traumatic brain injury to be conducted with EFIC (http://www.clinicaltrials.gov: NCT00822900). Importantly, this study compares the responses that are generated when interactive methods (e.g., in-person meetings with an investigator presentation) or less interactive methods (e.g., surveys handed out) are used for community consultation. This study notes that public opinion in some individual events was not in favor of EFIC in general or even of personal enrollment in this trial in particular. Nevertheless, the overall average of responses favors EFIC and personal enrollment in the trial. This clinical trial is now ongoing even in the communities that had strong negative responses. Such an approach is consistent with a purely democratic philosophy: majority 452
www.ccmjournal.org
opinion decides the fate of the community. However, it may be worth further philosophical and ethical debate on this conclusion. Should more protection be provided for members of the community with minority opinions? That approach would be consistent with the protectionist stance toward minorities that we adopt in other aspects of public life. Another function of community consultation is allowing the investigator to share responsibility with the community for subjects who are hurt in a trial or who are upset after the trial. Adverse outcomes are much easier to defend and accept for situations and risks that "everyone knew about" and "most people thought were a good idea." The validity of this function requires that risks were adequately disclosed to the community participants. This study reports that participants perceive risk differently when presented in different formats. Participants in more interactive settings minimized their estimates of study risk compared with participants in less interactive settings. Although this study cannot determine exactly why this difference in perception occurred, it is easy to speculate that investigator enthusiasm or nonverbal cues about risk-benefit profiles influenced participants in interactive sessions. These differences in risk perception are important because past critiques of public consultation in EFIC trials focused primarily on whether risks were adequately disclosed (13). The present data might suggest that less interactive methods are a more conservative estimate of public opinion and might be preferred for providing fair assessment of risk. We must continue collecting rigorous data about community consultation and other aspects of EFIC. Progress in acute care research depends on having a solid and contemporary ethical basis for conducting research on vulnerable patients who cannot consent for themselves. The present study provides an excellent example of how investigative teams can study and make specific meaningful conclusions about these practices. Similar studies should be embedded in all trials employing EFIC.
REFERENCES 1. CIson CM: The letter or fhe spirit. Consent for research in CPR. JAMA 1994; 271:1445-1447 2. Abramson NS, Meisel A, Safar P: Deferred eonsenf. A new approach for resuscitation research on comatose pafienfs. JAMA 1986; 255:2466-2471 3. Kafz J: The Nuremberg Code and the Nuremberg Trial. A reappraisal. JAMA 1996; 276:1662-1666 4. Rickham PP: Human experimentation. Code of efhics of fhe world medical associafion. Deelarafion of Helsinki. Br Med J 1964; 2:177 5. Ellis GB: OPRR Reports: Informed Consenf-Legally Effecfive and Prospeotively Obtained. Augusf 12, 1993. Available af: http://www. hhs.gov/ohrp/policy/hsdc93-03.hfml. Accessed Augusf 13, 2013 6. Nichol G, Huszti E, Rokosh J, etal: Impact of informed consent requirements on cardiac arrest research in the Unifed Sfafes: Exception from consent or from research? Resuscitation 2004; 62:3-23 7 Hiller KM, Haukoos JS, Heard K, ef al: Impacf of fhe Final Rule on fhe rafe of clinical cardiac arresf research in the Unifed Sfafes. Aead Emerg Med 2005; 12:1091-1098 8. Sferz F, A Singer E, Böffiger B, et al: A serious threat fo evidence based resuscifation within fhe European Union. Resuseitation 2002; 53:237-238 9. Dickerf NW, Mah VA, Biros MH, ef al: Consulfing Communifies When Patients Cannot Consent: A Mulficenter Study of Community February 201 4 • Volume 42 • Number 2
Editorials Consultation for Research in Emergency Settings. Crit Care Med 2014; 42:272-280 10. 21CFR50.24-Code of Federal Regulations Title 21: Part 50. Protection of Human Subjects. Section 50.24. Exception from informed consent requirements for emergency research. October 2, 1996; Revised April 1,2013 11. Baren JM, Biros MH: The research on community consultation: An annotated bibliography. Acad Emerg Med 2007; 14:346-352 12. Halperin H, Paradis N, Mosesso V Jr, et al; American Heart Association Emergency Cardiovascular Care Committee; American
Heart Association Council on Cardiopulmonary, Perioperative and Critical Care: Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's "Exception from informed consent requirements for emergency research": A special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: Endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine. Circulation 2007; 116:1855-1863 13. Grassley C: Americans should not be on a game show in U.S. emergency rooms and ambulances. Am J Bioeth 2010; 10:9-10
Outcomes in Elderly Patients Resuscitated From Cardiac Arrest: Is Age an Independent Predictor?' Ciaudio Sandroni, MD Anseimo Caricato, MD Department of Anaesthesiology and Intensive Care Catholic University School of Medicine Rome, Italy
M
ortality after cardiac arrest is high. Less than 20% of patients resuscitated from in-hospital cardiac arrest (IHCA) survive to hospital discharge (1). Advancing age is associated with worse outcomes after critical illness (2), and cardiac arrest make no exception. Survival to discharge after IHCA consistently decreases by 2% every 5 years of age above 65 (3), and according to recent evidence (4), less than 10% of IHCA victims above 65 years are alive at 1 year. However, the nature of the association between age and survival after cardiopulmonary resuscitation (CPR) is debated. Although some investigators reported that increasing age is an independent factor for mortality after cardiac arrest (5), others did not (6). In general, age seems to be less important in determining final outcome than event variables, like initial cardiac rhythm, witnessed status, or the interval between cardiac arrest and resuscitation interventions (7). Furthermore, separating the effect on outcome of age from that of comorbidities which are naturally associated with ageing is difficult. Finally, the lower survival rates observed in older victims of cardiac arrest may be due to a higher prevalence of withdrawal of life-sustaining therapies (WLST) due to perception of poor long-term outcome in this category of patients (8).
'See also p. 289. Key Words: aged; do-not-resuscitate order; outcome; prognostication; resuscitation The authors have disclosed that they do not have any potential conflicts of interest. Copyright © 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0b013e3182a52192
Critical Care Medicine
In this issue of Critical Care Medicine, Seder et al (9) present the results of a retrospective evaluation of recent registry data from six regional percutaneous coronary intervention centers in the United States. They compared the rates of survival and good neurological outcome (Cerebral Performance Categories 1 or 2) of 129 unresponsive cardiac arrest survivors older than 75 years with those of 625 patients 18-75 years old. Patients were matched for presenting rhythm, witnessed status, bystander CPR, and total ischémie time. On univariate analysis, resuscitated patients older than 75 years were less likely to survive to hospital discharge (33% vs 46%, p = 0.009) and to survive with good neurological outcome at 6 months (26.4% vs 40.5%, p = 0.003) than younger patients. However, they were also more likely to have do-not-resuscitate (DNR) orders (65.9% vs 48.2%, p < 0.001) and to undergo WLST (61.2% vs 47.5%, p - 0.005). Age more than 75 years was independently associated with poor outcome, but this association disappeared when DNR status was added to a multivariate logistic regression analysis model. Among variables included in the model, presence of DNR had the highest odds ratio for poor neurological outcome. Seder et al (9) did not report the reasons for which the DNR orders were made. These may have included the presence of other comorbidities not considered in the study model. Another reason could have been a diagnosis of severe hypoxicischemic brain damage (all patients were unresponsive at study inception). Prediction of a poor neurological outcome, usually based on a series of clinical or electrophysiological tests, is a major reason for WLST (10). Unfortunately, most of these predictors have recently been demonstrated to be much less accurate than previously believed (11, 12). In the study by Seder et al (9), among 385 patients for whom a DNR order was placed, 28 survived to hospital discharge and nine had good outcome at 6-month follow-up, which suggests that the attitude of the treating teams toward resuscitated patients may have been exaggeratedly pessimistic in some cases. Another reason for prescribing DNR could have been the perception of a short length or poor quality of future life. www.ccr-njournaLorg
453
Copyright of Critical Care Medicine is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
