(Stroke. 1996;27:232-237.)
© 1996 American Heart Association, Inc.
Articles |
Agreement on Disease-Specific Criteria for Do-Not-Resuscitate Orders in Acute Stroke
From the Stroke Program, Department of Neurology, Buffalo General Hospital, State University of New York at Buffalo (A.V.A., P.M.P.); and the Stroke Research Unit (A.V.A., J.W.N.) and the Clinical Ethics Centre, Sunnybrook Health Science Centre and Centre for Bioethics (E.M.M.), University of Toronto, Ontario, Canada.
Correspondence to Dr A.V. Alexandrov, Stroke Research Unit, 20754 Bayview Ave, Toronto, Ontario, Canada M4N 3M5.
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Abstract |
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 Top Abstract IntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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Background and Purpose The do-not-resuscitate (DNR) order is a mechanism of withholding cardiopulmonary resuscitation (CPR). The lack of DNR guidelines specific for acute stroke may result in many stroke patients receiving unnecessary and futile resuscitation and ventilator-assisted breathing.
Methods A prospective multicenter evaluation of disease-specific criteria for DNR orders in acute stroke was initiated using a modified Delphi process. The participants were the Canadian and Western New York Stroke Consortium members who are closely involved in caring for acute stroke patients and conducting clinical trials at the academic centers. Previously published provisional criteria were reviewed by the participants. Modifications were made to the criteria until statistically significant agreement (P<.05, z score, or 67% similar answers) was achieved.
Results Disease-specific criteria for DNR orders in acute stroke were discussed by 26 physicians in three rounds of the opinion survey. An agreement was reached that a "no resuscitation" decision is appropriate when any two of the following three clinical criteria are present (the degree of agreement is given in parentheses): severe stroke (88%, P=.00007), life-threatening brain damage (73%, P<.01), and significant comorbidities (92%, P=.00003). The poor prognosis implied by these criteria should be discussed whenever possible among physician(s), the patient, and family members before the decision to withhold CPR is made. Eighty-one percent of the participants agreed that these disease-specific criteria are appropriate for clinical use (P=.0008).
Conclusions Disease-specific criteria for DNR orders were developed to supplement general DNR policies for patients with hemispheric brain infarction and intracerebral hemorrhage during the first 2 weeks of stroke. A significant agreement was reached by a panel of physicians that patients with acute stroke should not be resuscitated if these disease-specific criteria are met.
Key Words: hospitalization • outcome • resuscitation orders
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Introduction |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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In both the Canadian and US healthcare systems, practice guidelines limit physicians' discretion in choice of treatment.1 General guidelines for do-not-resuscitate (DNR) orders were first introduced in 19762 and have been regularly updated since. Current general guidelines for DNR orders cover a wide range of terminal illnesses, of which stroke is one of the most common. Every year 550 000 people in the United States have a stroke (nearly 1% of all hospital admissions nationwide), and 150 000 of them die.3 Cardiopulmonary resuscitation (CPR) does not improve the outcome in patients with severe acute stroke4 5 ; however, life-sustaining measures may also include mechanical ventilators. In a recent study,6 170 patients with acute stroke were admitted to an intensive care unit and received life support with ventilators; only 28% were discharged and only 8% of all patients survived more than 1 year. Survival and its predictor (higher Glasgow Coma Scale scores) were similar in the study by Grotta et al,7 which suggested that elective intubation may achieve satisfactory outcome. However, no definite conclusions could be drawn from both studies, since a control group was absent.
Mortality during the first week of stroke is determined primarily by compression of vital centers in the brain stem due to brain swelling and herniation.8 9 Although reliable clinical predictors of fatal outcome in hypoxic-ischemic coma were established,10 a broad spectrum of neurological signs and impairment of consciousness at stroke onset make prognostication unclear. Stroke differs from other terminal illnesses in that the patient may be alert and have cognitive capacity for several days after the onset of hemiplegia but before the development of coma. Therefore, early prognosis of acute stroke is sometimes difficult to assess even for an experienced observer, although this is essential for institution of DNR. Disease-specific guidelines for CPR in acute stroke were developed,11 but these guidelines do not aid DNR decisions particular to acute stroke.
The patient's wishes concerning CPR and mechanical ventilation are paramount in "no resuscitation" decision making.12 The patient, however, must be fully apprised of the risk-benefit ratio of the procedure7 and needs to be informed when the intervention is likely to be unsuccessful. Thus, aggressive treatment of the hopelessly ill patient is inadvisable when such treatment would only prolong dying by bringing no improvement.12 The controversy in physicians' attitudes toward management of patients with acute stroke13 14 indicates that criteria are needed to determine when a patient with acute stroke has a grave prognosis and thus will be unresponsive to CPR and mechanical ventilation.
Discussions regarding the provision of life-sustaining treatment, particularly CPR, have focused attention on the ethical issues arising from the use of "futility" as a standard for nontreatment and whether the likelihood of benefit should be determined by patients rather than physicians.1 2 13 15 16 Any attempt to guide decision making in this area has to be assessed in the clinical environment. Given that stroke is a major cause of mortality and a risk factor for subsequent stroke, stroke patients may be uniquely situated to participate in CPR/DNR discussions.
To evaluate current practice of DNR orders in acute stroke, we studied 450 consecutive stroke patients admitted to a Toronto hospital.5 Of these, three patients received CPR and none of them survived hospital admission; 31% received DNR orders and 83% of those died. A "no resuscitation" decision was associated mainly with the severity of stroke (Canadian Neurological Scale17 scores less than 5.0), age more than 60 years, and type of stroke. As a result of this pilot study, we suggested provisional criteria5 for "no resuscitation" decisions.
Since "no resuscitate" decisions in acute stroke are associated with both medical uncertainty and inevitable plurality of values,18 we aimed to assess the agreement on the provisional criteria among physicians involved in management of patients with acute stroke to identify factors considered to be of prognostic significance and thus to develop recommendations for further studies and the use of DNR orders in acute stroke.
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Subjects and Methods |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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A multicenter evaluation of the provisional criteria was initiated among physicians of the Canadian and Western New York Stroke Consortiums. Participating physicians are the neurologists and a neurosurgeon who demonstrated their involvement in management of patients with acute stroke and conducting clinical trials at academic medical centers in Canada19 and New York State (see "Acknowledgments"). A modified Delphi process20 21 was used to accomplish a prospective peer review of the proposed criteria by the participants. An invitation letter, provisional criteria,5 and a standard questionnaire were sent to the Consortium members. Responses had to be received no later than scheduled deadlines. After the answers were analyzed, the definitions of the criteria were modified, and a new draft of the guidelines and a new questionnaire were developed by the group of principal investigators (A.V.A., P.M.P., E.M.M., and J.W.N.) and modified according to the participants' recommendations. Finally, the participants commented on the appropriateness of the proposed criteria for clinical use.
All 36 members of the Consortiums as listed on July 1, 1994, received invitations to participate in the study and standard questionnaires. The questions were formulated so that the participants would answer "yes" or "no." Agreement was considered significant when the probability value was less than .05 (z score) or when more than 67% of the reviewers answered similarly. The z score22 evaluates the significance of a single proportion with a null hypothesis of a 50/50 chance of "yes"/"no" answers among the observers. No repeated assessment of the reviewers' opinion was used, and therefore no further statistical tests were used. After each round of circulation of the proposed criteria and questionnaires, the participants received a synopsis of data indicating the degree of agreement achieved. Only the final draft of the disease-specific recommendations is presented here.
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Results |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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Thirty-six invitations were mailed and twenty-six physicians responded (72%), comprising 16 Canadian and 10 US physicians. A one-page set of disease-specific recommendations for DNR orders in acute stroke were developed after three rounds of the study ("Appendix I"). The recommendations consisted of the definitions of clinical criteria for DNR orders and general statements regarding withholding CPR in patients with acute stroke.
Initially, 22 of 26 reviewers agreed with a one-page format chosen
for the criteria (85%, P=.0002) (Table
).
During the first round, 17 of 26 reviewers considered the provisional
criteria5 appropriate for clinical use (65%,
P=.06, NS), and certain changes to the definitions of
clinical criteria were recommended (see below). After three rounds of
improving the criteria and definitions, six of those who initially
considered the criteria inappropriate changed their opinion, and three
reviewers did not change their opinion. Only two reviewers who first
evaluated the criteria as appropriate then reconsidered their opinion.
The final agreement on the appropriateness of the disease-specific
criteria for clinical use was 81%, or 21 of 26 reviewers
(P=.0008).
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During the first round, the participants were asked several questions
regarding the general issues of "no resuscitation" decision
making and management of patients with severe stroke (Table
).
Thus,
instead of primary discussions of a DNR order and contrary to the
principle of implied consent for CPR, 20 of 26 reviewers suggested that
initial consent must be obtained for the use of CPR (77%,
P=.003). Therefore, a DNR order is considered a secondary
action after the decision not to perform CPR is made. Of 26
participants, 21 agreed that CPR does not alter the fatal outcome in
severe stroke (81%, P=.0008), emphasizing that CPR may be
used in patients with minor or brain stem stroke with no significant
comorbidities (see "Appendix I"). Therefore, unless requested by
patients or an appropriate surrogate according to patients'
preferences, CPR should not be recommended as a treatment option in
patients with severe stroke. The use of advanced cardiac life support
and mechanical ventilation was not recommended in patients with severe
stroke by 18 of 26 reviewers (69%, P<.03). Also, 18
reviewers agreed that the "no resuscitation" decision should be
made irrespective of the patient's age (P<.03). According
to 24 of 26 reviewers, a DNR order withholds CPR only, and the
appropriateness of other treatments should be assessed on its own
merits (92%, P=.00003). Although stroke is an unexpected
and often irreversible event, warning signs (ie, transient
ischemic attacks) are common. Since the major risk factor for
stroke is stroke itself, advance directives should be encouraged in
patients with warning signs of stroke or after nonfatal stroke,
according to 18 of 26 reviewers (69%, P<.03).
During the first round, only 15 of 26 reviewers agreed that severe stroke and irreversible brain damage are sufficient grounds for a DNR order (58%, P=.2, NS), and they offered a number of suggestions to improve the definitions. Therefore, the second and third rounds were designed to achieve consensus on the definitions of the clinical criteria for DNR orders (see "Appendix I"). Thus, new definitions of severe stroke and life-threatening brain damage were suggested for review. Final agreement for the definition of severe stroke was achieved by 22 of 26 reviewers (88%, P=.00007). Nineteen of 26 reviewers agreed with the definition of life-threatening brain damage (73%, P<.01), and 24 of 26 reviewers agreed with the definition of significant comorbidities (92%, P=.00003).
Twenty-one reviewers recommended further consensus development involving neurosurgeons, neurocritical care specialists, and bioethicists (81%, P=.0008). Also, it was noted that currently available imaging data lack precision in quantifying inevitably fatal brain damage in hemispheric ischemic stroke and brain stem stroke. Overall, Canadian and US physicians had similar opinions when the agreement on the outlined issues was considered separately for each Consortium.
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Discussion |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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The result of this study was a one-page set of disease-specific recommendations for DNR orders in acute stroke, developed to supplement general DNR policies during the first 2 weeks of stroke. The proposed clinical criteria for DNR orders reflect the factors associated with DNR decision making and mortality after stroke reported in previous studies.4 5 8 23 24
Firm prognostic criteria for hypoxic-ischemic coma have been established.10 Our proposed recommendations set criteria that, according to physicians' experience, indicate fatal outcome despite life-sustaining interventions before the development of coma secondary to stroke. These disease-specific criteria for DNR orders were not designed as perfect predictors of mortality, but when present they should alert clinicians on the likely futile outcome of resuscitation.
The key concept behind these recommendations is that, unless requested by patients or appropriate surrogates, CPR or advanced cardiac life support including use of mechanical ventilation should not be initiated in patients who meet the proposed clinical criteria. This does require a rethinking of the methods used to inform and involve patients and families in decision making about CPR. The participants agreed that the "no resuscitation" decision should be made irrespective of the patient's age and be based on grave prognosis and "futility" of intervention. However, medical futility as a justification for a DNR order was inconsistently applied in a recent study,15 emphasizing that vague definitions of futility may contribute to this problem.16 A specific definition of futility must include evidence of no survivors after CPR.16 In the absence of a study designed to evaluate "quantitative futility"16 of CPR and mechanical ventilation in acute stroke, we attempted to develop definitions of clinical conditions associated with inevitably fatal stroke on the basis of currently existing outcome data.4 8 9 17 25 26 27 28 29 30 31 Furthermore, doctors should not have absolute power to withhold interventions regardless of the patient's wishes.16 We therefore indicated in the recommendations that, after the prognosis was established, the "no resuscitation" discussions should be held whenever possible among physician(s), the patient, and family or appropriate surrogates. Only after that may the DNR order be written in the chart. The inconsistency inherent to unilateral DNR orders15 16 may affect patients with severe stroke, since only 8% of these are capable of informed decision making.5 Also, 8% of those with impaired cognition did not have any relative or surrogate available at the time of a "no resuscitation" decision made by physicians.5 Therefore, a minority of acute stroke patients may require unilateral DNR orders that should be well grounded. We agree that medical education about futility and the DNR order must be improved, and a specific definition of futility must be used.16 Moreover, joint decision making satisfies the ethical principle of patient autonomy,16 and we suggest
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Acknowledgments |
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Dr Alexandrov was supported in part by a postgraduate fellowship from the Department of Medicine, University of Toronto. We wish to thank Drs Antonio Culebras, Stephen J. Phillips, and Peter A. Singer for thorough peer review and the improvements suggested to prepare the manuscript for its submission. The authors thank the participants listed below for their contribution of ideas and constructive criticisms.
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Footnotes |
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1 Fatal outcome of ICH is associated with a volume of >60 mL on CT scans. Currently available data lack precision in quantifying imaging criteria and size of life-threatening hemispheric infarctions and infratentorial lesions.
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Appendix I |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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Disease-Specific Criteria for Do-Not-Resuscitate Orders in Acute Stroke
These criteria supplement general DNR policies to aid the specific use of DNR orders in patients during the first 2 weeks of stroke.
Background
Patients suffering acute stroke are facing the
irreversibility of
the neuronal damage if treatment is delayed. Controversial clinical
attitudes toward stroke are partly grounded in effective interventions
to prevent death but as yet limited effectiveness of treatment of brain
damage to reduce subsequent disability. The unexpectedness of stroke
and difficulties with prognosis complicate decision making.
The early mortality rate following stroke is high mainly due to brain swelling and herniation during the first week and from systemic complications thereafter.
Consent should be obtained for the use of CPR and mechanical ventilation as a treatment option. A DNR order is a secondary action that occurs after the decision not to perform CPR.
Ethics
Physicians and nurses are primarily responsible for the quality of
information concerning stroke prognosis and the way it is
presented to the patient and family. The final decision about
resuscitation should be made by an informed patient (when possible) or
an appropriate surrogate. Acute stroke patients are often incapable of
participating in discussions regarding CPR due to aphasia, dementia,
and impaired consciousness, thus being unable to understand and
appreciate the nature and consequences of CPR. Therefore, the choice of
an informed substitute increases the physician's responsibility. This
decision must be made irrespective of the patient's age and according
to the patient's expressed preferences or best interests (when
preferences are not known).
Applicability and Institutional
Issues
These criteria, suggested for patients with ischemic
stroke and intracerebral hemorrhage, should be
updated regularly and may be modified if new treatment strategies prove
effective in severe stroke.
The criteria apply mainly to the acute phase of stroke (the first 2 weeks); general DNR policies are also applicable during and after this time.
The criteria are intended to supplement, not replace, existing DNR policies in institutions. Staff should be informed of the issues identified.
Team Issues and Management
Nurses
should be informed of the prognosis and patient's
preferences and best interests.
If the attending physician has doubts, it is prudent to wait and to obtain a second opinion from another physician.
A DNR order should not be interpreted as a decision to discontinue patient care and treatment. The appropriateness of any treatment and nutrition should be evaluated on its own merits.
General
Considerations
Dying is a natural process. An intervention is futile
if it
prolongs dying and brings discomfort but no improvement (ie, if it does
not alter the fatal outcome and is of no benefit). Such intervention
may also be considered harmful since the risk of systemic complications
of subacute stroke is high in severely disabled survivors.
Stroke is an unexpected and often irreversible event. However, warning signs (eg, transient ischemic attack) are common, and since the major risk factor for stroke is stroke itself, prior discussions and advance directives regarding the patient's preferences on resuscitation should be encouraged.
Unless requested, CPR and mechanical ventilation should not be recommended as a treatment option in patients with severe stroke since these are often futile or not in the best interests of these patients. CPR may be appropriate in patients with minor and brain stem strokes with no significant comorbidities.
Clinical Criteria for
DNR Orders
A DNR order may be written any time that two of the
following
clinical criteria are present and the prognosis has become clear
for and shared whenever possible between physician(s), patient, and
family (or appropriate surrogate).
1. Severe
Stroke
Clinically severe stroke produces persisting (more than 24
hours)
and sometimes deteriorating neurological deficit, often with early
impairment of consciousness leading to total dependency of the patient
in activities of daily living. The patient must have little or no
active movement on at least one side of the body, with either impaired
consciousness, global aphasia, or lack of response indicating cognition
(Glasgow Coma Scale score of <9, Canadian Neurological Scale score
of <5.0).
2. Life-Threatening Brain
Damage
Life-threatening brain damage is associated with brain stem
compression caused by large intracerebral
hemorrhage (ICH), usually with
intraventricular extension; large hemispheric
infarction with midline shift; infratentorial strokes involving
multiple levels in the brain stem; or cerebellar
lesions.*
3. Significant Comorbidities
The
following nonneurological conditions are important risk
factors for death within the first month after stroke: pneumonia,
pulmonary embolism, sepsis, recent myocardial infarction,
cardiomyopathy, and life-threatening
arrhythmias. These comorbid factors should be considered part
of expected consequences of severe stroke pointing to an
increased likelihood of death in the subacute phase of
stroke.
that this should be achieved whenever possible. The concept of implied consent for CPR is evolving now and will likely be replaced by the view that an informed consent should be obtained for the use of CPR.32
Two rounds were necessary to achieve significant agreement on the clinical criteria for DNR orders that reflect current views on reliable predictors of early death after stroke. Several original studies were used to define severe stroke,8 17 25 26 life-threatening brain damage,8 26 27 28 29 30 and significant comorbidities.8 9 30 31 The criteria "severe stroke" and "life-threatening brain damage" identify patients with brain stem compression due to transtentorial herniation likely to lead to fatal deterioration. Further study33 is underway to review previous imaging criteria for brain herniation34 35 and quantify lesion volume and midline shift producing irreversible brain stem compression particular to acute stroke.
In addition to general policies,36 37 disease-specific criteria have been developed, for example, for "locked-in" and persistent vegetative-state patients.38 39 Such disease-specific statements contain valuable information for both junior and senior medical staff because they summarize the current knowledge on the disease and its management, as well as provide detailed criteria on which to base both the clinical decision and the discussion with the family. These disease-specific guidelines, however, are not applicable to the group of patients addressed by the disease-specific criteria in the present study.
It is encouraging that there was no difference in opinion between the Canadian and US physicians on the clinical criteria for DNR orders and other questions in this study. In Canada, patients with acute stroke stay in the hospital far longer than in the United States because of placement problems, and the survivors of the acute phase of a severe stroke represent a large burden on the hospital budget.40 However, the major determinants of costs of acute care are social (ie, availability of nursing homes) and not medical.40 Therefore, prevention of inappropriate interventions may not only reduce the length of hospital stay in accord with present trends in managed care financing but, most importantly, it will be consistent with patients' best interests.41
There was a significant degree of agreement among the participants that these disease-specific criteria are appropriate for clinical use in the present format. However, to avoid the potential for the criteria to become a self-fulfilling prophecy or a "cookbook" of medicine, the reviewers recommended further consensus development and prospective studies involving neurosurgeons, neurocritical care specialists, and bioethicists. Furthermore, the present criteria should be reviewed periodically to accommodate new quantitative prognostic data (imaging and clinical) as well as therapies that are effective for treatment of patients with acute stroke.42 43
In conclusion, these disease-specific criteria and recommendations for DNR orders in acute stroke are suggested not to replace but to supplement existing general DNR policies and management guidelines.44 It is anticipated that the disease-specific criteria will facilitate informed decision making and stimulate further studies to refine prognostic data for rational prevention of unnecessary interventions in terminally ill patients with acute stroke.
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Appendix II |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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Participants in a Multicenter Collaborative Group on the Disease-Specific Criteria for Do-Not-Resuscitate Orders in Acute Stroke
Members of the Canadian Stroke Consortium (CSC): Brian A. Anderson, MD, St Boniface Hospital, University of Winnipeg (Manitoba); Michel Beaudry, MD, Clinique Neurologique du Saguenay, Chicoutimi (Quebec); Andre Bellavance, MD, PhD, Hopital Charles LeMoyne, Universite de Sherbrooke, Greenfield Park (Quebec); Gilles Bernier, MD, Hopital Notre-Dame, Montreal (Quebec); Sandra E. Black, MD, Sunnybrook Health Science Centre, University of Toronto (Ontario); Christopher F. Bladin, MBBS, FRACP, Stroke Research Unit, University of Toronto (Ontario); Robert Coté, MD, Hopital General de Montreal (Quebec); Robert Duke, MD, Hamilton Civic Hospitals, Hamilton (Ontario); David Howse, MD, Division of Neurology, Queens University, Kingston (Ontario); Keith Hoyte, MD, Calgary General Hospital, University of Calgary (Alberta); Andrew Kertesz, MD, St Joseph's Hospital, University of Western Ontario, London (Ontario); Louise-Helene Lebrun, MD, Hopital St Luc, Universite de Montreal (Quebec); Eric M. Meslin, PhD, Clinical Ethics Centre, Sunnybrook Health Science Centre, and Centre for Bioethics, University of Toronto (Ontario); Gerard Mohr, MD, FRCS(C), Jewish General Hospital, McGill University, Montreal (Quebec); John W. Norris, MD, Stroke Research Unit, University of Toronto (Ontario), CSC Chairman; Stephen J. Phillips, MD, Victoria General Hospital, Dalhousie University, Halifax (Nova Scotia); and Frank L. Silver, MD, Toronto Western Hospital, University of Toronto (Ontario).
Members of the Western New York Stroke
Consortium (WNYSC):Andrei V. Alexandrov, MD, Stroke Program, Western
New York
Neuroscience Center, State University of New York (SUNY) at Buffalo,
Buffalo, Study Coordinator; Curtis Benesch, MD, Department
of Neurology, University of Rochester (NY); Antonio Culebras, MD, VA
Medical Center, SUNY at Syracuse; Linda Hershey, MD, VA Medical Center,
SUNY at Buffalo; Frederick Munschauer, MD, Stroke Program, Buffalo
General Hospital, SUNY at Buffalo; Bruce Naughton, MD, Buffalo General
Hospital, SUNY at Buffalo; Walter A. Olszewski, MD
,
VA Medical Center, SUNY at Buffalo; Patrick M. Pullicino, MD, PhD,
Stroke Program, Western New York Neuroscience Center, SUNY at Buffalo,
WNYSC Chairman; M. Reza Samie, MD, Mercy Hospital, SUNY at
Buffalo; and Bradley Traux, MD, Erie County Medical Center, SUNY at
Buffalo.
Received July 5, 1995; revision received October 25, 1995; accepted October 25, 1995.
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References |
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TopAbstractIntroductionSubjects and Methods Results Discussion Appendix IAppendix IIReferences |
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