120110P - THE SCOPE OF MANAGEMENT FOR THE PATIENTS THAT ARE LABELED AS DNR (What Can And What Cannot Be Done For Patients Who Are Rendered DNR).

Paper written by Professor Dr. Omar Hasan Kasule Sr.

1.0 DEFINITION OF TERMS

Discussion of DNR requires clarification of basic terms: terminal illness, end of life, death, euthanasia, resuscitation, withholding, withdrawal.

Terminal illness, maradh al mawt, is illness from which recovery is not expected. The definition is based an empirical probability estimation reflecting experience of similar patients in the past who succumbed to their disease. Being a probability statement, terminal illness does not apply to all patients.

End of life / approaching the end of life: This term is used to refer to patients likely to die soon (days to a few months).

Death process: death is not an event but a process with a time line that may be long or short. An established death process is progressive failure of the cardio-respiratory system. The process once established is irreversible. The process is picks up momentum as death approaches. Death from whatever cause has a common final path: cardio-respiratory failure which means denying cells and tissues perfusion of oxygen and nutrients necessary for cell metabolism. Brain tissue being the most sensitive to oxygen and nutrient deprivation will die first. There is however a chicken and egg argument here. If the brain dies first, the cardiorespiratory system will die soon after because its coordinated function requires that some brain centers remain active and alive. It is very important to know the point of irreversibility of the death process because interventions beyond this point are futile. The examples of conditions normally cited can be classified into two categories: (a) established death process (b) pre the death process.

Euthanasia is an act of commission or an act of omission that hastens death with the aim of saving the patient from pain or further suffering, physical or psychological.

Resuscitation: is a series of medical measures taken to reverse cardio-respiratory failure. The term CPR should be avoided because it can have two meanings: (a) traditional chest compressions and oxygenation (b) all measures of reviving cardiac and respiratory function both basic and advanced.

DNR in some countries is a normal clinical decision based on facts that should be disclosed to the patient or a substitute decision maker to obtain informed consent

DNR in KSA is a clinical decision with no input from the patient or substitute decision maker. There is a requirement to just inform the family.

Paternalism is an attitude of physicians that they know what is best for the patient and therefore make decisions without respecting the patient’s autonomy

Futility refers to medical interventions that will not have a nett and lasting impact on cardio-respiratory decline. Survival after CPR is generally low 15-20% (BMA Guidelines 2007). The process may have its risks like rib fracture. Survivors may have brain injury due anoxia before restoration of cardio respiratory function.

Withholding life support means not starting any artificial and radical cardio-respiratory support measures in a patient deemed to be in an established death process. Withdrawal of life support means stopping some or all artificial cardio-respiratory support measures that may be followed by death of the patient.

2.0 CANDIDATE CONDITIONS FOR DNR

2.1 Criteria vs examples

In order to define what procedures are involved in DNR we need to have a consensus on what conditions qualify for DNR. It is not possible to produce criteria for conditions that qualify for DNR because they would be very difficult to operationalize.  Most often examples are given as guidelines. There is therefore wide variation among consultants in DNR decisions.  

2.3 Examples from KFMC CPP No 1430-60

1. Advanced incurable malignancy, 2. advanced multi-organ failure, 3. irreversible, severe, and documented brain damage 4. advanced cardiac, hepatic, or pulmonary disease 5. ioperable, life threatening congenital heart disease, fatal chromosomal or neuromuscular disease 6. Irreversible, severe, mental and physical incapacity.

2.2 Examples from ARAMCO

1. Advanced incurable, end-stage malignancy 2. End-stage organ failure 3. advanced irreversible brain damage 4. end-stage renal disease if renal replacement therapy is not feasible 5. Inoperable congenital anomalies incompatible with life 6. Fatal chromosomal abnormalities 7. brain death.

3.0 PRE-DEATH AND ESTABLISHED DEATH PROCESS

3.1 Established death process

A DNR order for a condition within the death process is understandable because of the futility in reversing the cardio-respiratory collapse. If resuscitation is attempted, the patient will recover for a short time and succumb again the only other alternative being maintaining artificial life support for an indefinite time with no hope of recovery.

The DNR order for such cases is usually a short time before final death because these conditions can only be ascertained for patients already in the death process.

The KFMC CPP is appropriately titled ‘Allowing Natural Death’ because these patients are already in an irreversible trajectory to certain death and there is no need for futile artificial interference.

In a view expressed in another paper, the DNR order is a normal medical decision based on evidence and informed consent/assent/no dissent by the patient or the family.

3.2 Pre the death process

Most of the conditions mentioned in the KFMC and ARAMCO documents precede but are not part of an established death process. Patients with these conditions can survive for various periods of time until they succumb to their illness or to some other illness. Because of the poor prognosis for these conditions, artificial heroic interference beyond normal maintenance or supportive treatment of any kind is not appropriate. This includes CPR in addition to other surgical or medical procedures. These patients should therefore be not be under the DNR policy but should be covered by another policy more in the line of palliative or terminal care. They should also be admitted from the beginning to wards without advanced life support facilities in the knowledge that these will not be needed. It should be part of the policy that they are not admissible to the ICU with appropriate explanations for their families.

Cardio-respiratory collapse in these patients may be due to the primary condition or may not be but the distinction is only of theoretical interest because in a situation requiring urgent intervention, there is no time to ascertain the cause of the collapse.  The use of DNR orders for such patients creates many moral issues that require discussion. The DNR order is not based on whether they will benefit from the resuscitation or not. It is based on the presumption that even if they benefit from resuscitation, they will succumb sooner or later to their disease so the resuscitation is futile. The futility of resuscitation in this case is related more to the remote outcome and not on the current cardio-respiratory collapse.

A DNR order can be justified on the basis of the doctrine of futility but what futility? (immediate cardiorespiratory or the remote disease outcome).

A DNR order would be illegal if done to save the patient from further suffering because that would be passive euthanasia.

  

4.0 DNR WHAT IT COVERS AND WHAT IT DOES NOT COVER

4.1 Principal Components of a DNR order

DNR stands for ‘do not resuscitate’ and is withholding  specific measures that will reverse cardio-respiratory collapse. These measures are considered heroic and futile for patients in an established death process. They are useful for patients with cardio-reversible respiratory collapse enabling them to survive longer for a reasonable time.

4.2 KFMC

The KFMC CPP No 1430-60 mentions the components of DNR as: bag-mask ventilation, intubation, chest compression, code medications, and defibrillation

4.3 SAMSO

The SAMSO MSP 102 classifies components of DNR into two categories. (a) measures that shall be withheld for DNR patients: cardio pulmonary resuscitation, endotracheal intubation, and initiation of mechanical ventilation. (b) Measures that may/may not be withheld: inotropic/vasoactive drugs, admission to ICU/step down unit, renal replacement therapy (hemo, peritoneal, or continuous hemofiltration), blood or blood products transfusion, total parenteral nutrition, repletion of tests, diagnostic or therapeutic procedures that do not contribute to end of life care, aggressive pulmonary hygiene protocol.

In addition supportive care is continued during the DNR status: nursing care and cleanliness, clearance of secretions (oral, nasal, endotracheal etc), water and food, pain management, supplementary oxygen, iv fluids, enteral feeding, comfort, management of symptoms, spiritual support.

4.4 BRITISH MEDICAL ASSOCIATION (Guidelines 2007)

The guidelines do not distinguish between basic and advanced life support measures on the argument that the ethical issues involved are the same.

Components of DNR: chest compressions, attempted defibrillation with electric shocks, injection of drugs and ventilation of the lungs. In some cases spontaneous cardiac function may be restored with prompt use of an electric shock alone.

4.5 SINGAPORE

An empirical study showed that measures instituted during DNR were: oxygen therapy (38.9%), nasogastric tube insertion and feeding (30.6% and 33.3% respectively), intravenous fluid administration (33.3%), blood investigations (33.3%), opioid use (33.3%) and antibiotic use (29.2%). Measures withdrawn were intravenous fluid administration (36.1%), hourly monitoring of parameters (22.2%), antibiotics (13.9%), high dependency care (12.5%) and nasogastric tube feeding (6.9%).

4.6 SUMMARY

There are basically 3 measures that can be included in a DNR order: (a) cardiopulmonary resuscitation involving chest compressions and oxygenation, (b) endotracheal intubation, and (c) mechanical ventilation. These measures may/may not be applied in the order that they are given. Clinicians will automatically apply the next procedure if the first one fails. Additional measures that be included: (d) defibrillation (e) vaso active /ionotropic medication.

Life support measures not related to cardio-respiratory support can continue during DNR: renal dialysis, blood transfusion, parenteral nutrition, pulmonary hygiene, normal treatment eg antibiotics.

Supportive care during DNR should continue including: Clearance of secretions (oral, nasal, endotracheal, etc.), hydration, nutrition, pain management, supplemental oxygen, sedation, antipyretics, anti emetics, relieve of constipation, relief of urinary retention, relief of dypnea and cough.

5.0 CONCLUSIONS/RECOMMENDATIONS

5.1 It is difficult to distinguish between basic and advanced life support measures (al umuur bi maqasidiha)

5.2 To avoid confusion DNR orders should specify the measures intended

5.3 We need to carry out empirical research on the DNR process at KFMC: indications, decision process, outcome (death/survival), family reactions etc.

120211L - ETHICO-LEGAL ISSUES IN EMERGENCY TREATMENT

Background material by Professor Omar Hasan Kasule Sr. for Year 6 ethics lecture at the Faculty of Medicine King Fahad Medical City 11^th February 2012

1.0 INFORMED CONSENT

·         Describe situations in which an emergency room patient becomes incompetent

·         Can an advance directive be used to intervene in an emergency room?

·         Explain treatment in an emergency when there is no time to get consent.

·         Explain treatment decisions in emergency rooms for incapacitated patients.

2.0 REFUSAL OF EMERGENCY TREATMENT

·         Explain guidelines for dealing with refusal or emergency treatment for competent and incompetent patients.

·         Describe guidelines on life saving resuscitation after attempted suicide if the patient refuses consent.

·         Discuss the relevance if advance refusal for emergency resuscitation.

3.0 PHYSICIAN RESPONSIBILITY IN ER

·         Explain what a health care should do in emergency if he has to undertake a procedure he is not authorized to carry out.

·         Discuss the obligation of an off-duty doctor to treat patients in an airplane or on a road accident.

4.0 ISSUES OF CONFIDENTIALITY AND DISCLOSURE

·         Describe guidelines for maintaining Privacy and Confidentiality in a busy ER

·         Discuss the admission of relatives into the resuscitation room.                 

·         Describe guidelines on disclosure of medical information to the media in cases of a major accident involving many people

·         Discuss disclosure of information to the police about patients in an emergency room

·         Describe guidelines on forensic searches of unconscious patients for alcohol blood levels.

·         Discuss guidelines for dealing with domestic and child abuse in the emergency room as well as information disclosure.

5.0 END OF LIFE DECISIONS

·         Give examples of ER conditions for which intubation and ventilation will be withheld

·         Can a DNR order be written in ER?

6.0 ISSUES OF RESOURCE ALLOCATION

·         Describe the basis for triage in the ER to determine prioritizing patient treatment

·         What admission criteria will you use if several patients present in the ER simultaneously and facilities are not enough?

7.0 RESEARCH

Explain research in the ER with no consent

120211L - ETHICO-LEGAL ISSUES IN CLINICAL RESEARCH

Background material by Professor Omar Hasan Kasule Sr. for Year 6 ethics lecture at the Faculty of Medicine King Fahad Medical City 11^th February 2012

1.0 GENERAL

Distinguish between therapeutic and non-therapeutic research.

Define the concept ‘good clinical practice’ and list its main principles.

Discuss issues relating to inclusiveness (emphasis on: include minorities and women in research).      

Explain the application of confidentiality in clinical research (use anonymized data, no disclosure of subject details to researchers until after consent).

2.0 GOVERNANCE

Describe the composition of an institutional research ethics committee

Describe the functions of an institutional research ethics committee (emphasis on: scientific quality of the research, competence of the researchers, risks to research subjects, disclosures, compensation, payments to researchers and participants, confidentiality of the data).

3.0 AUTONOMY

Explain the application of the principle of autonomy in clinical research (emphasis on: informed consent, consent needed even for records based research that is published anonymously if non-health care workers have access before anonymizing). 

Explain why informed consent in clinical research is more important than in normal patient treatment.

List information items that patients involved in clinical research must be told (emphasis on: what is the treatment, evidence about the treatment and missing information that necessitates research, how the treatment differs from the standard treatment, available alternatives treatments, likely risks and benefits, measures to ensure safety).

Explain ethico-legal guidelines on withdrawal from research at any time.

4.0 VULNERABLE RESEARCH SUBJECTS…1

Explain ethical guidelines on recruitment as research subjects of people in a dependent capacity such as prisoners, students, and employees.

Explain ethico-legal guidelines on material inducements for research subjects.

Discuss the obligation of members of the armed forces to be research subjects without consent.

5.0 VULNERABLE RESEARCH SUBJECTS…2

Explain ethico-legal guidelines on consent to research by children (emphasis on: consent by competent children endorsed by parents, consent by parents, consider special vulnerability of children’s physiology, research in child’s interests so parents cannot consent to research that is against the child’s interests, benefits must outweigh the harm, extra precautions to prevent abuse, parental consent can be overridden by the child,).

Explain ethico-legal guidelines on consent to research by mentally incompetent persons (emphasis on: decision by proxy or advance consent or refusal, benefits must outweigh the harm, extra precautions to prevent abuse,).

6.0 EMBRYO OR FETAL RESEARCH

Describe 2 sources of embryos for research and explain the difference in ethical consideration between them (embryos can be surplus from IVF procedures or can be created specifically for research. Creation of embryos for the sole purpose of research is a more serious issue).

List research that requires use of embryos (emphasis on conception, contraception, infertility, inherited diseases).

Explain ethical guidelines on research on fetal tissue (emphasis: fetal tissue from spontaneous abortion creates few problems. Fetal tissue from induced abortion created the appearance that the abortion was for purposes of obtaining the tissue, consent is needed, no financial inducements, the timing, place, and type of termination procedure must not be related to the requirements of research).

7.0 RESEARCH USING HUMAN MATERIAL

Describe ethico-legal guidelines on genetic testing of biological samples obtained from individuals (emphasis on: informed consent must be obtained if the test is not anonymized).

Describe ethico-legal guidelines on research on material from living donors (emphasis on: approval by ethics committee, information on the how long the material will be stored and the benefits and risks of the research, informed consent is needed to take more material than is needed for therapeutic purposes and specific consent to a specific research, rules of confidentiality. There is no need for consent to test surplus anonymized material). 

Describe ethico-legal guidelines on research on material from deceased donors (emphasis on: consent by family after full information: what tissues to retain, the purpose and nature of the research, confidentiality).

8.0 PROBLEMS OF FRAUD IN RESEARCH:

Describe various forms of fraud in research (emphasis on: failure to follow standards GCP, failure to get consent, data falsification, plagiarism, including as researchers senior professor who did not actually participate in the research, researchers not trained in ethics, falsifying authorship).

Describe methods of avoiding research malpractices (emphasis on: training researchers in GCP and ethics, ethical and scientific review of the research proposal, detailed recording of all research activities, the principal researcher should be personally involved in the research activities, quality assurance and audit programs, whistleblowers on fraud).

120312L - THE ETIQUETTE OF THE PHYSICIAN, Adab Al Tabiib, 2

Lecture for 4^th year medical students Faculty of Medicine King Fahad Medical City on 12^th March 2012 by Dr Omar Hasan Kasule Department of Bioethics Sr. Faculty of Medicine

1.0 RESPECTING RIGHTS OF THE PATIENT: THE RIGHT TO AUTONOMY

1.1 INFORMED CONSENT

No medical procedures can be carried out without informed consent of the patient except in cases of legal incompetence. The patient has the purest intentions in decisions in the best interests of his or her life. Others may have bias their decision-making. The patient is free to male decisions regarding choice of physicians and choice of treatments.

Physician assisted suicide, active euthanasia, and voluntary euthanasia are illegal.

Informed consent requires disclosure by the physician, understanding by the patient, voluntariness of the decision, legal competence of the patient, offering the patient alternative approaches with recommendation of the physician on the best course of action, decision by the patient, and authorization by the patient to carry out the procedures.

Consent can be by proxy in the form of the patient delegating decision making or by means of a living will. Advance directives, proxy informed consent by the family are made for the unconscious terminal patient on withholding or withdrawal of treatment.

Consent is limited to what was explained to the patient except in an emergency.

Refusal to consent must be an informed refusal (patient understands what he is doing). Refusal to consent by a competent adult even if irrational is conclusive and treatment can only be given by permission of the court.

Doubts about consent are resolved in favor of preserving life.

Spouses and family members do not have an automatic right to consent. A spouse cannot overrule the patient’s choice.

A do not resuscitate order (DNR) is signed for cases in the death process for whom intervention in the form of aggressive cardio-respiratory support has no net and lasting benefits. It should not be misused as a form of euthanasia.

2.0 DISCLOSURE AND TRUTHFULNESS

As part of the professional contract between the physician and the patient, the physician must tell the whole truth. Patients have the right to know the risks and benefits of medical procedure in order for them to make an autonomous informed consent. Deception violates fidelity. If disclosure will cause harm it is not obligatory. Partial disclosure and white or technical lies are permissible under necessity. Disclosure to the family and other professionals is allowed if it is necessary for treatment purposes. Physicians must use their judgment in disclosure of bad news to the patient.

3.0 PRIVACY AND CONFIDENTIALITY

Privacy and confidentiality are often confused. Privacy is the right to make decisions about personal or private matters and blocking access to private information. The patient voluntarily allows the physician access to private information in the trust that it will not be disclosed to others. This confidentiality must be maintained within the confines of the Law even after death of the patient. In routine hospital practice many persons have access to confidential information but all are enjoined to keep such information confidential. Confidentiality includes medical records of any form. The patient should not make unnecessary revelation of negative things about himself or herself. The physician can not disclose confidential information to a third party without the consent of the patient. Information can be released without the consent of the patient for purposes of medical care, for criminal investigations, and in the public interest. Release is not justified without patient consent for the following purposes: education, research, medical audit, employment for insurance.

4.0 FIDELITY

The principle of fidelity requires that physicians be faithful to their patients. It includes: acting in faith, fulfilling agreements, maintaining relations, and fiduciary responsibilities (trust and confidence). It is not based on a written contract. Abandoning the patient at any stage of treatment without alternative arrangements is a violation of fidelity. The fidelity obligation may conflict with the obligation to protect third parties by disclosing contagious disease or dangerous behavior of the patient. The physician may find himself in a situation of divided loyalty between the interests of the patient and the interests of the institution. The conflict may be between two patients of the physician such as when maternal and fetal interests conflict. Physicians involved in clinical trials have conflicting dual roles of physicians and investigators.

120313P - DNR OUTSTANDING ETHICO-LEGAL-FIQHI ISSUES

Presentation at a Grand Round on DNR Department of Medicine, King  Fahad Medical City Riyadh on 13^th March 2012 by Dr Omar Hasan K Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Department of Bioethics King Fahad Medical City.

Abstract

The paper asserts that consideration of DNR should relate exclusively to cardio-respiratory failure. It analyses practical issues arising in the implementation of DNR from the perspectives of maqasid al shari’at and qawa’id al shari’at. The issues covered relate to uncertainties, protection of life, protection of the patient from potential harm, conservation of resources, and implementation issues. The paper proposes that DNR orders shall be written for patients in an established death process i.e cardio-respiratory failure beyond Young’s point ‘z’. Patients with terminal incurable conditions who develop acute and reversible cardio-respiratory arrest should be resuscitated if they will have a nett benefit from CPR lasting for a reasonable time. The paper proposes 5 components of DNR (cardiopulmonary resuscitation involving chest compressions and oxygenation, endotracheal intubation, mechanical ventilation, defibrillation, and vaso-active/ionotropic medication) that may be provided in any order and combination on a case by case basis. DNR patients on a case by case basis may/may not get renal dialysis, blood transfusion, parenteral nutrition, pulmonary hygiene, normal treatment e.g. antibiotics. All patients irrespective of their DNR status deserve supportive care: clearance of secretions, hydration, nutrition, pain management, supplemental oxygen, sedation, antipyretics, anti emetics, relieve of constipation, relief of urinary retention, relief of dypnea and cough. Recommended measures for improving DNR processes are: training workshops on EOL ethical issues for physicians and nurses, DNR orders specifying interventions intended/prohibited, respecting the autonomy of physicians who have conscientious objections to DNR, more psycho-social support for DNR families, more empirical research on the DNR process, and regular audits of DNR decisions.

Introduction

The 2 main objectives of DNR orders are to respect patient autonomy and to prevent unnecessary non-beneficial intervention are not fulfilled well in practice[i]. Confusion in discussions and decision making about end of life issues arises from different perceptions of what terms mean. We need to start by clarifying the terminology used and the underlying conceptual basis. Most DNR policies provide procedural and technical guidelines[ii] [iii] but do not explore the conceptual basis which leaves the physician in a lurch when the situation at hand does not fit the guidelines perfectly and he has no conceptual or methodological basis for independent thinking. Algorithms can help physicians make EOL intervention decisions quickly under pressure of time[iv] but no specific case will fit properly with the algorithm necessitating equipping the physician with basic principles that can be applied to all situations. This paper is educational and is an attempt to provide a conceptual basis for analyzing ethical issues that relate to DNR using principles of Islamic Law. The paper does not use original sources nor does it refer to past or current legal opinions, fatawa, because its purpose is to provide a physician with simple axioms that can enable reasoning through and understanding complicated ethical issues. The final decisions in specific cases should be referred to the competent authorities in each jurisdiction. The approach of equipping physicians with the maqasid and qawa'id tools for analysis of ethical issues has two main advantages: (a) it teaches them to fish instead of giving them fish (b) each ethical case is unique in its circumstances and no one legal opinion, fatwa, can cover all the nuances involved thus leaving room for personal analysis and understanding by the physician.

Methods

The purposes of the Law, maqasid al shari’at[v], and the principles of the Law, qawa’id al fiqh[vi], provided a conceptual framework for analyzing practical issues related to DNR orders. The issues were identified from a pubmed literature search using the key word ‘DNR’ and covering a span of about 30 years of DNR experience. The issues were analyzed as they related to the principle of certainty, qa’idat al yaqeen, and the principle of preventing harm, qa’idat al dharar. The issues were also analyzed as they relate to the purpose of preserving life, hifdh al nafs, and the purpose of preserving resources, hifdh al mal.

Results

Issues related to the principle of certainty, qa’idat al yaqiin

Terminal illness, maradh al mawt, defined as illness from which recovery is not expected, is also called the End of life (EOL) or approaching the end of life (AEOL). The period is variable from a few days to several months. The definition of terminal illness is based an empirical probability estimation reflecting experience of similar patients in the past who succumbed to their disease. Being a probability statement, terminal illness does not apply to all patients since diagnosis and prognosis are not 100% exact. There are anecdotal cases of terminally patients living a normal life for years but these are the exception and reflect that probability estimates by humans are not perfect because of limited knowledge and understanding of empirical knowledge, ‘ilm al shahadat, and complete ignorance of the unseen, 'ilm al ghaib. The basic and default position is that of the certainty, yaqiin, that illness is reversible. A diagnosis of terminal illness must be based on strong clinical evidence interpreted within previous institutional experience. This is in conformity with the principle of the Law that certainty cannot be voided by a doubt or a speculation, al yaqiin la yazuulu bi al shakk (Majallat Article No ).

Death and the moment of its occurrence are uncertain in this era of technology. Death is not an event but a process with a time line that may be long or short. Theoretically death starts at birth because cells and tissues die and degenerate. During the period of growth and development until about 35 years the repair or regenerative processes are dominant over the degenerative ones. After that the degenerative processes increase until a point that regeneration and repair are overwhelmed and death can ensue without specific pathology and this is the basis for the inevitability of death. Pathological insults to the body structure or functions hasten the degenerative processes and may hasten the process of death. Degeneration affects all organs and functions of the body but the final common pathway is cardio-respiratory failure that impairs perfusion of cells by oxygen and nutrients necessary for metabolism. Brain tissue being the most sensitive to oxygen and nutrient deprivation will die first. There is however a chicken and egg argument here. If the brain dies first, the cardio-respiratory system will die soon after because its coordinated function requires that some brain centers remain active and alive. If the cardio-respiratory function dies first the brain will not get oxygen and nutrients and will die. Cardio-respiratory failure is progressive but hastens as final death approaches. There is a point of irreversibility along this death time line called Young’s ‘point z’; it separates prolongation of life from prolongation of death. Beyond this point is an established death process. All forms of life support, basic and advanced, before this point have some benefit albeit temporary. Advanced life support beyond this point is futile. It is unfortunate that many patients beyond point z are in intensive instead of palliative care because physicians are reluctant to decide on withholding or withdrawing life support[vii]. The definition of legal death is under the principle of custom, qa'idat al 'aadat. It is based on the existing consensus among physicians at that time that is considered the usual custom and is therefore legally binding, al 'aadat muhakkamat (Majallat Article No,).  This implies that the definition can change with progress of medical science and is still valid according to the principle that changes in the customary are accepted, la yunkiru taghayyur al… (Majallat Article No ).

Perioperational DNR is in a grey uncertain area. It is not possible to tell whether cardiopulmonary arrest in the perioperational period is due to the disease or is due to the anesthetic drugs[viii].  There is ambiguity and diversity of perceptions and implementation regarding perioperational DNR orders[ix] [x]. Some hospitals questioned the perioperational suspension of DNR orders[xi] [xii]. Some hospitals automatically suspended DNR orders while others offered no, limited or full resuscitation[xiii]. Some dealt with the matter on a case by case basis[xiv].  The questioning is greater if the suspension of DNR orders is being considered for palliative surgery[xv]. According to the principle of certainty, we should avoid doubtable things and this is reinforced by the hadith 'leave what causes you doubt to what does not da' ma yuriibuka ila ma la yurribuka  (    ). I would conclude that DNR orders shall be suspended in the perioperational period and can be reinstituted after recovery from the effects of the anesthetic.

Pre hospital DNR has uncertainties associated with it. In emergencies ambulance personnel by mistake resuscitate persons with advance directives against resuscitation because of lack of proper patient identification or unavailability of the DNR documents[xvi] [xvii] [xviii] or undertake futile resuscitation[xix]. Emergencies such as chocking or suicide attempts with DNR orders create complex legal problems[xx]. According to the general principle mentioned above, ambulance personnel should resuscitate whenever they are in doubt. This is because of the overriding purpose of protecting life, maqsad hifdh al nafs.

Issues Related to Purpose of Protection of life, maqsad hifdh al nafs

Artificial Life Support is a series of medical measures taken to reverse cardio-respiratory failure in order to fulfill the purpose of protecting life. It can be basic life support (BLS) such as chest compressions or may be advanced life support (ALS) such as intubation and mechanical ventilation. Resuscitation has a low survival rate at best less than 20%[xxi] [xxii]; survival is determined more by the underlying disease than the resuscitation efforts[xxiii] which calls for a re-evaluation of instituting resuscitation measures in the first place.

The doctrine of futility is invoked when the interventions have no nett and lasting impact on cardio-respiratory decline and may even have risks such as rib fracture. Allow Natural Death (AND) roughly translated means do not interfere by advanced life support measures for patients in an established death process. Dot Not Resuscitate (DNR) or Do Not Attempt Resuscitation (DNAT) is a clinical decision not to institute advanced life support measures such as intubation and mechanical ventilation. In practice AND and DNR are equivalent but some providers thought that AND was ambiguous but more family oriented[xxiv]. In futile cases, withholding life support means not starting any artificial and radical cardio-respiratory support measures and withdrawal of life support means stopping some or all artificial cardio-respiratory support measures followed soon after by death. It is easier to withhold than to withdraw according to the principle yghtafar fi al ibtida ma la yughtafar fi al intiha (Majallat Article No,.  ). Mortality among patients on DNR is high; one author asked the rhetorical question ‘Do patients die because they have DNR orders, or do they have DNR orders because they are going to die?[xxv]. A serious ethical issue arises if patients die because of DNR orders.

Do Not Treat (DNT) falls under the doctrine of advance directives (living will) in which the patient or his/her representative exercise prospective autonomy to reject treatment considered futile for their specific disease condition. If the intervention is of minimal or of temporary benefit and it has side effects that make the nett benefit zero or even negative, it is moral not to intervene. DNT refers to intervention against the original condition like metastatic cancer. Once a DNT decision has been made the patient has to be transferred to a hospice or palliative care in the hospital or at home where high tech interventions are not available and are not offered. It is emotionally difficult to maintain a DNT order in a high tech environment because of the human tendency to ‘do something’ even if futile.

Euthanasia is an act of commission or an act of omission that hastens death with the aim of saving the patient from pain or further suffering, physical or psychological. Active euthanasia is an act of commission that involves a positive and deliberate action that will hasten death. Passive euthanasia of omission that involves failing to take action to save life. In Islamic Law there is no essential difference between commission and omission because actions are judged by their intentions, al umuur bi maqasidiha, and both share the same intention, hastening death. Passive euthanasia (PE) is exercised by withholding advanced or basic life support measures and is most commonly undertaken in the form of DNR orders[xxvi].

Patient mismanagement due to conceptual confusion: If DNR is misinterpreted as DNT the patient is neglected and may not receive routine care because he is thought to be dying. When DNT is misinterpreted as DNR, we may not resuscitate patients who arrest even for reversible conditions not related to the terminal disease. Writing a DNR order for a patient with an incurable condition who is not in an established death process is a form of passive euthanasia. What is appropriate in such a case is DNT order accompanied by transfer to palliative/hospice.

Issues related to Principle of Prevention of harm, qa’idat al dharar

Consent for DNR: The patient or the family make the crucial decisions about DNR[xxvii].  DNR and Advance directives assure the patient of prospective autonomy[xxviii]. Consent by the patient is the most effective way of fulfilling the purpose of protecting life because the patient has an inherent interest in the life of the patient and could not in normal circumstances seek self-harm. Patients’ choice of DNR or otherwise are affected by their perceived quality of life[xxix], their perception of their poor prognosis and understanding of hospice care. Patient gave consent to DNR and some signed the consent themselves while the family signed for others. Poor physical or psychological condition, consultant concerns, and family wishes were reasons for not involving some of the patients in DNR discussion[xxx].

Violation of the patient autonomy for DNR, causes harm to the patient. Non-medical emotional or social considerations may lead to ignoring the patient’s autonomous choice of DNR because CPR as an intervention is invested with a lot of emotional impact[xxxi]. A school system did not honor the DNR decision reached by a 16-year old cardiac patient with the parents and primary care physician because they could not tolerate the emotional pain to teachers and other students watching a student go through the agonies of death without doing anything[xxxii] [xxxiii]. When DNR status is discussed or decided late in the course of the illness the patient’s capacity to participate in the decision is limited and his autonomy could not be respected[xxxiv] [xxxv].

Consent for CPR is protection of patient interests. A lot of discussion is about the right of autonomy to consent to DNR without the realization that patients should be given an opportunity to consent to CPR[xxxvi]. The autonomous right to consent to CPR is not discussed because of the presumption being that every CPR should be carried out for every cardiopulmonary collapse for example New York State passed a law making resuscitation the default position unless refused by the patient[xxxvii]. A more positive approach would be to perform CPR if it is beneficial unless the patient refused[xxxviii]. From a historical perspective, DNR policies emerged to check the excesses of technology related to a universal presumption of consent to CPR[xxxix] [xl]. Existence of the DNR policy is an inducement for physicians to seek consent for CPR and not act on presumptions[xli]. CPR in emergencies is carried out without consent[xlii] since there is no time to go through the normal routines of informed consent.

Paternalism , an attitude of physicians that they know what is best for the patient and therefore make decisions without respecting the patient’s autonomy, can harm the patient’s interests. Paternalism occurs in 2 ways in EOL decisions: (a) instituting CPR automatically without informed consent (b) DNR without patient or family involvement. Physicians in many cases do not discuss with patients and base DNR decisions on perceived low quality of life which may be an underestimate; patients could have a different view if they were consulted[xliii]. A Canadian study indicated physician dominance of DNR decisions by establishing the strongest predictors of DNR orders as: physician prediction of survival, physician perception of the patient’s preferences, physician diagnosed organ dysfunction, physician determined medical diagnosis, and the patient’s age[xliv] leaving little or no room for patient-driven choice. Over the years a movement has been building up against physician paternalism because unilateral decisions on withholding and withdrawing violate patient dignity[xlv] and autonomy. The US Veterans Health Administration had a policy forbidding a physician from entering a DNR order against patient objections even if he had good reasons to believe that resuscitation was futile[xlvi].

Family assent to DNR is protection of the patient’s interests in jurisdictions that treat DNR as a clinical decision by the physician with no input from the patient or substitute decision maker. The requirement that the family be informed of the decision before implementation is in practice a form of seeking assent because no physician will sign and implement a DNR order against loud protests by the family. Relieving the family of the burden of being part of an informed decision process for DNR, in my opinion, is a very judicious consideration of local culture and family dynamics. Members of the family would not like to take responsibility for a decision that can end life.

Age discrimination harms patient interests. It is unethical to base DNR decisions on age alone reasoning that old people have to die anyway. Protection of health operates equally at all ages but the practice has been different. Several studies found a significant association between old age and DNR orders with age being the main independent factor of DNR[xlvii] after controlling for disease severity as a confounding factor. The discrimination became worse at higher ages[xlviii].  There is no quantitative reason for withholding CPR on the basis of age[xlix]. Many of the elderly may want to be resuscitated but may have inadequate knowledge of the process with the result that physician preferences for DNR predominate[l].

Issues elating to purpose of conservation of resources, maqsad hifdh al maal

Resource over-utilization: The commonsense view that DNR will result in less utilization of ICU resources is not true in practice especially when the orders are written too late in the course of the disease. DNR patients appeared to use more costly resources. They stayed longer and had higher hospital charges[li]. Savings were made only if DNR orders are written earlier in the course of the disease[lii]. It is not possible to write DNR orders very early in the course of disease because the irreversibility of the death process may not be yet apparent.

Inappropriate utilization of Intensive Care Unit (ICU) resources: ICU is a specialized multi-disciplinary unit with concentration of advanced life support skills and technology. It however misuses its expensive resources in many ways.  For clarity I would suggest some synonyms for ICU that allude to potential misuse: Futile Care Unit (FCU) because of high mortality and low discharge to normal life, Wasteful Care Unit (WCU) because of high technology resources wasted in futile interventions, Extremist Care Unit (ECU) because of high-end technologies, Mortuary Care Unit (MCU) because dead corpses are maintained on life support, and Hospice Care Unit (HCU) because of admitting hopeless cases that should be in palliative care. As we rethink ICU operations we should set discharge to normal life as a key performance indicator (KPI) because it is a reflection on admission decisions in addition to the care given in the ICU. Poor outcomes from the ICU reflect admission of futile cases.

Palliative Care saves resources while providing humane care. It is a resource saving alternative for terminal patients who cannot get nett benefit from life support or conventional treatment. Existence of a large palliative care unit alongside an ICU will result in considerable saving of resources because DNR and DNT patients would be admitted directly to palliation instead of the more expensive ICU care. Palliation has to do with making the death process as comfortable as is possible. Palliative care is in low tech environments: the home, in a hospice section of a hospital, or in a freestanding hospice. Palliative care has several modalities: pain control, spiritual preparation, emotional and psychological support, communication, appropriate symptom management using available essential drugs/medication without over-treating, nutrition support, and occupational therapy. Alternative/complimentary therapies can be used for example aromatherapy relaxing treatment, massage, meditation, relaxation, and music. Care is taken to prevent development of complications such as infection and pressure sores.

Implementation issues

DNR policies and guidelines: Health organizations differed in their DNR policies, some had formal policies, some had informal policies, and some had no policies. Formal policies were associated more with larger institutions that were accredited and had ethics committees[liii]. Implementation of the DNR concept varied by organization[liv]. Institutional documentation of discussions and decisions about DNR was poor[lv].

Knowledge of physicians regarding DNR: Physician knowledge of DNR issues is variable. The term "DNR" was found to be ambiguous and the rationale for DNR orders was also not well articulated in practice[lvi]. Junior doctors writing DNR orders had a poor understanding of what DNR meant[lvii]. Residents had limited knowledge and skills regarding DNR[lviii]. They were uncomfortable with EOL decisions. They misinterpreted the terms ‘DNR’ and ‘futility’, and did not practice according to what they were taught in the formal curricula[lix].

Practices of physicians regarding DNR: Inconsistency in physician practices relating to DNR reflected underlying uncertainties in DNR policies.  It was found that 11% of physicians who wrote a DNR order for a patient would still do chest compressions when the patient arrested[lx]. In Taiwan 77.6% of physicians would inform terminal patients and families about DNR but 58.4% did not know whether allowing natural death was legal[lxi]. Ideally DNR patients should not be in the ICU but it was found that DNR was initiated by ICU physician in 80% of cases and by most responsible physician (MRP) in 20% of cases; ideally the MRP who knows the patient best should write the DNR order. There were delays in completing signatures, some orders were not even signed, and discussions with the family were not documented[lxii].

Identification of DNR patients: In the stress of emergencies mistakes could be made in identifying DNR patients. Hospitals use color coded wristbands but the colors vary and confusion could occur[lxiii].

Deciding candidates for DNR

Lack of DNR criteria: In order to define what procedures are involved in DNR we need to have a consensus on what conditions qualify for DNR. In my visits to some hospitals I have seen policies and guidelines giving examples if the types of conditions for DNR. There is therefore wide variation among consultants in DNR decisions in the absence of more definitive criteria. The following are some of the examples given: 1. advanced multi-organ failure, 2. irreversible, severe, and documented brain damage 3. advanced cardiac, hepatic, or pulmonary disease 4. inoperable, life threatening congenital heart disease, 5. fatal chromosomal or neuromuscular disease 6. irreversible, severe, mental and physical incapacity, 7. advanced incurable, end-stage malignancy  8.  end-stage renal disease if renal replacement therapy is not feasible 9. brain death.

Developing a criterion for DNR requires distinguishing an established death process from the pre-death process. A DNR order for a condition within the death process is understandable because of the futility in reversing the cardio-respiratory collapse. If resuscitation is attempted, the patient will recover for a short time and succumb again the only other alternative being maintaining artificial life support for an indefinite time with no hope of recovery. The DNR order for such cases is usually a short time before final death because these conditions can only be ascertained for patients already in the death process. The term ‘Allowing Natural Death’ is appropriate because these patients are already in an irreversible trajectory to certain death and there is no need for futile artificial interference. Resuscitation of these patients will have no nett benefit lasting for any reasonable time.

Pre-established death process: Most of the examples mentioned above precede but are not part of an established death process. Patients with these conditions can survive for various periods of time until they succumb to their illness or to some other illness. Because of the poor prognosis for these conditions, artificial heroic interference beyond normal maintenance or supportive treatment of any kind is not appropriate. This includes CPR in addition to other surgical or medical procedures. These patients should therefore be not be under the DNR policy but should be covered by DNT policies. They should also be admitted from the beginning to wards or palliative care units without advanced life support facilities in the knowledge that these will not be needed. It should be part of the policy that they are not admissible to the ICU with appropriate explanations for their families. Cardio-respiratory collapse in these patients may be due to the primary condition or may not be but the distinction is only of theoretical interest because in a situation requiring urgent intervention, there is no time to ascertain the cause of the collapse.  The use of DNR orders for such patients creates many moral issues that require discussion. The DNR order is not based on whether they will benefit from the resuscitation or not. It is based on the presumption that even if they benefit from resuscitation, they will succumb sooner or later to their disease so the resuscitation is futile. The futility of resuscitation in this case is related more to the remote outcome and not on the current cardio-respiratory collapse. A DNR order would be illegal if done to save the patient from further suffering because that would be passive euthanasia.

Criteria for DNR: My simple understanding is that DNR can only be valid if the patient is in the death process beyond the z point. The principle of certainty, qa’idat al yaqiin,  guides the determination of the point ‘z’ as a point of irreversible cardio-pulmonary collapse. The purpose of protecting life, hifdh al nafs, is irrelevant beyond the z point and the purpose of resource preservation, hifdh al mal, becomes operational. DNR for any untreatable or incurable condition before an established death process is (a) a form of passive euthanasia.

Deciding contents of a DNR order

DNR stands for ‘do not resuscitate’ and is withholding specific measures that will reverse cardio-respiratory collapse. These measures are considered heroic and futile for patients in an established death process. They are useful for patients with cardio-reversible respiratory collapse enabling them to survive longer for a reasonable time. DNR does not mean do not care (Fields 2007[lxiv]). DNR patients should not be neglected and should get all other types of supportive care.

We can reach the following conclusions from reading the literature and review of hospital practices: 1. There are basically 5 cardio-respiratory life support measures that can be included in a DNR order: cardiopulmonary resuscitation involving chest compressions and oxygenation, endotracheal intubation, mechanical ventilation, defibrillation, and vaso-active/ionotropic medication. These measures are applied in any order and in any combination.  2. Life support measures not related to cardio-respiratory support may/may not continue during DNR: renal dialysis, blood transfusion, parenteral nutrition, pulmonary hygiene, normal treatment e.g. antibiotics. 3. Supportive care during DNR should continue including: clearance of secretions (oral, nasal, endotracheal, etc.), hydration, nutrition, pain management, supplemental oxygen, sedation, antipyretics, anti emetics, relieve of constipation, relief of urinary retention, relief of dypnea and cough.

Recommendations

(a) Training workshops should be held for all concerned healthcare givers on the ethical issues of EOL with special emphasis on: understanding differences among: DNR, DNT, and euthanasia; appreciation that DNR does not mean stopping conventional and supportive care (b) Specifying in the DNR orders the interventions permitted and those prohibited for example ‘do not intubate’[lxv]. (c) Respecting the autonomy of physicians who have conscientious objections to DNR with discussions on how they can function in the healthcare team in the future. (d) Providing more psycho-social support for DNA families (e) Undertaking empirical research on the DNR process in the institution: indications, decision process, outcome (death/survival) (f) Carrying out regular audits especially of mistakes and malpractices will help develop institutional learning and institutional memory; help change and development[lxvi]; and help in evaluation[lxvii].