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Casual consent to treatment  muhammad saaiq
Casual consent to treatment  muhammad saaiq
Casual consent to treatment  muhammad saaiq
Casual consent to treatment  muhammad saaiq
Casual consent to treatment  muhammad saaiq
Casual consent to treatment  muhammad saaiq
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Casual consent to treatment muhammad saaiq

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  • 1. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman Medical Ethics In Debate Casual Consent to Treatment: A Neglected Issue in our Health Care System While internationally the medical community has effected a drift from the traditional concept of simple consent to the more sophisticated notion of informed consent, consent still continues to be a largely neglected component of our health care system. There is lack of recognition of the significance of consent to treatment and hence the consent process is taken as a casual formality both by our doctors as well as patients. Most of the time the doctors are forced by local cultural factors and social customs to compromise on the principles of consent taking. This compels them to take added responsibility and a great professional risk. There is a dire need to rectify this trend because an informed consent not only ensures the patient’s autonomy, self-determination and informed decision-making but is also a reaffirmation of the doctor’s ethical and legal responsibilities towards his patient. This article highlights the various conceptual and methodological processes involved in the consent with identification of the deficiency areas in our own system. KEY WORDS : Consent to treatment, Informed consent. Muhammad Saaiq* Khaleeq-Uz-Zaman** *Postgraduate Resident, Department of Surgery, PIMS, Islamabad. **Professor and Head, Department of Neurosurgery, PIMS, Islamabad. Address of Correspondence: Dr. Muhammad Saaiq Medical Officer, Department of Surgery, PIMS, Islamabad, Pakistan. E-mail muhammadsaaiq5@gmail.com Introduction In the last few decades the traditional paternalistic model of patient care has been replaced by one that emphasizes patient autonomy, empowerment and full disclosure of facts. The entire health care delivery is being redesigned from the patient’s perspective.1 It is generally agreed worldwide that patient’s consent is imperative for any medical intervention unless he is incapable of consenting or the doctor is legally required to intervene without the patient’s wishes.2 Even if it is a legal requirement it is ethically more appropriate to obtain the patient’s consent.3 The various aspects of medical management for which consent is considered mandatory include clinical examinations, investigations, therapeutic interventions and participation in clinical research etc.4,5 Whereas internationally there is growing recognition of the significance of consent both for the doctor as well as the patient, our doctor community still continues to be largely informal about this very key component of health care system. What Constitutes a Consent? Generally speaking consent is a mutual agreement, compliance or understanding between the patient and his care provider whether a person or institution. Traditionally consent has been described as either implied or expressed. Implied consent is the one which is neither expressed verbally nor in writing and is provided by the demeanour of the patient. In most of our clinical or hospital practice it is the valid form of consent for routine clinical assessment and treatment. e.g. a patient visiting a clinic for the management of common Ann. Pak. Inst. Med. Sci. 2006; 2(3):207-212 207
  • 2. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman cold, sore throat etc. In such cases the implied consent would be sufficient for routine clinical examination, however more complex examination such as that of private parts or female breast would require an explicit consent. Expressed consent refers to the one which is expressed either verbally or in writing. The expression should be done in the presence of a third party unrelated to the patient so that this evidence remains unbiased in the event of any allegation against the doctor . 4-6 In view of the ever-increasing new diagnostic and therapeutic interventions and sophisticated research protocols, the traditional concept of consent has much changed. Now it is an era of informed consent which adequately satisfies both ethical as well as legal aspects of the standard medical practice of the contemporary era. 7-9 What are the essentials of an informed consent? Historically there has been a move from simple to informed consent and the basic philosophy behind this drift is to ensure patient’s autonomy and right of self- determination in making informed decisions about his health. 10,11 Meaningful and fair consent essentially demands that the patient be given sufficient and understandable information to make a valid choice of his treatment. The consent form is not equivalent to consent.12 The important attributes of informed consent are information 13 , trust 14 and lack of coercion 15 . The consent process often starts at the time of admission with implicit rules of communication and participation being conveyed to the patient. The signing of consent form just prior to surgery while on the ward tends to be a re- affirmation of the same. Modern law emphasizes patient’s consent to treatment not only through liability for unauthorized touching ( i.e. criminal assault and/ or civil battery) but also through liability for negligence. 16 New dimensions to the traditional informed consent are being sought and there is reconsideration of even legislative provisions regarding public education programmes towards consent related specific issues such as disclosure , advance directives, substitute decision, emerging treatments and advocacy. 17 The generally agreed elements to be disclosed for eliciting informed consent from a legally competent patient include the diagnosis, the patient’s prognosis if untreated, alternative treatment options , the success rate of each option, the risks and benefits of the anticipated procedure and the patient’s right to exercise veto power over a doctor’s decision. 16,18 How much risk-information to deliver in the consent process? Over the last two decades particularly there has been an explosive expansion of the understanding of how people perceive and code risks and then use this information in decision making. 19-21 There is growing evidence that the patients often employ simplifying heuristics in judgment and decision making. These heuristics may lead to bias in how people interpret information. However much of our understanding of risk perception is based on laboratory studies and it is less clear whether risk perception in the real world exhibits the same pattern and biases. 19 Legally, informed consent for therapy is a risk- management tool that functions essentially as a release of liability. If the patient is informed of all the expected or potential side-effects or toxicities of a treatment, he cannot sue the doctor or hospital because those side effects occur. The moral doctrine of informed consent is derived from a respect for the patient's autonomy as well as the patient's vulnerability. The physician's goal is not to minimize liability but to help the patient make the best decision. These two goals are not necessarily incompatible but they often lead to different attitudes towards informed consent and different decisions about what information needs to be shared with patients. If the goal is risk-management then informed consent forms should be encyclopaedic providing the "whole truth" to the patient. This would however not meet the moral goals of shared decision-making because few patients could make sense of such data. This may elicit even counterintuitive and probably counter-productive response. 9 Even in the developed countries patients don’t realize the purpose and significance of information and consent form. In a country like the United States, less than 31% of the people have any college education. In this context expressing and understanding risk is a problem equally faced by doctors and patients across the world. 22-24 Ann. Pak. Inst. Med. Sci. 2006; 2(3):207-212 208
  • 3. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman Consent taking in developing countries like ours! We in our set up are faced with yet more complicated issues. The stingy botherations are: What kind of information to deliver ? How much risk information to communicate? Whom to tell and Whom not to tell? When and how to communicate? etc. Since our society is suffering from a social divide, we in our clinical practice encounter two extreme varieties of people. i.e. the deprived and poor ones and the affluent and influential ones . The former strata , owing to their uneducated and ignorant behaviour prompt a ‘communication block’ on part of the dealing doctor while the latter group owing to their narcissistic behaviour cause an ‘empathy block’. As a result, effective communication is impaired at the very outset of doctor-patient interface. Not infrequently we encounter problems when we are about to break bad news to our patients. For instance a lady with breast cancer would be all set for surgery but the sons would insist on not disclosing any information to their mother about the diagnosis as well as the plan for surgery. In Neurosurgical practice we encounter yet more strange situations. For instance a patient with sciatica would seek our advice and when he is advised surgery, he would go away saying that he has heard of the risk of paraplegia and life long disability associated with spinal surgery. Similarly a patient with acoustic neuroma would be ready to undergo surgery but would disappear if the risk of facial palsy is communicated to him. These circumstances force us not to tell the patient all the likely risks involved in the anticipated procedure, however who can guarantee the ‘cure without any risk of complications’ . Still our patients would search for someone who can offer cure with no chance of risks whatsoever and at times end up with the so called 100% healers. Who is competent to consent to treatment? Anyone who can give a legally valid consent must be competent. There exists a fine balance between patient’s autonomy and self-determination on one hand and protection of the incompetent patient from potential harm on the other hand. Competence refers to the state in which a patient’s decision making capacities are sufficiently intact for their decisions to be honoured. 25 This capacity to make decisions is required for anyone to give a valid informed consent however informed consent requires more than this capacity, for example, trust and lack of coercion. More importantly there must be an understanding of what is being consented to . 14,15,26 Generally the current recommendation is that in non- emergency situations, individuals who are competent to give informed consent to treatment should be extended the right to refuse it as well. 27 Who are incompetent to consent? Incompetence refers to a status of the individual as defined by the functional deficits ( due to mental illness, mental retardation or other mental condition) judged to be sufficiently great that the person currently can’t meet the demand of a specific decision making situation weighed in light of its potential consequences. 25 Patient’s understanding of the information about treatment is the main determinant of his capacity to give informed consent. Incapacity is generally considered in terms of understanding and communication. 28-30 In England the law emphasizes a patient’s understanding of the information about the proposed treatment, potential risks and benefits of treatment and the consequences of not taking the treatment. 3 Thus any person would be considered unable to take a decision on mental treatment in question if he is unable to understand or retain the information relevant to the decision, unable to make a decision based on the information or unable to communicate a decision. 3 Mental disorders associated lack of insight would incapacitate the patient to consent for treatment . Most of the criteria for competence in current use emphasize cognitive rather than affective dimension of capacity to consent. Clinical experience indicates that affective disorders may impair competence in a detectable and identifiable way. In particular patients with major affective disorders can retain the cognitive capacity to understand the risks and benefits of a medication yet fail to appreciate its benefits. 31 Ann. Pak. Inst. Med. Sci. 2006; 2(3):207-212 209
  • 4. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman How should a doctor approach an incompetent patient? In cases where the patient is unable to give an informed consent to any treatment such as when the patient is unconscious or mentally incapable, the doctor’s duty to preserve life remains paramount. In non-emergency situations court approval is required for procedures such as sterilization, abortion, organ donation or experimental studies. 32 A patient's incapacity to give informed consent to one medical intervention should not be assumed to imply incapacity to give consent to all other interventions. Legally as well as ethically if a patient is incapable of giving consent to one intervention it does not necessarily imply incapacity in general . For example a patient suffering from schizophrenia may be capable of giving informed consent to the treatment of his diabetes but not to the treatment for his schizophrenia or vice versa. Thus each proposed intervention would require an independent assessment of the patient’ s particular capacity to give informed consent for that specific intervention. 25 A challenging situation arises when a clinician is required to assess a mentally ill patient’s capacity to give informed consent to a clinical examination. The law of the land in the form of mental health act for instance would solve such issues by ordering or requiring the doctor to examine the patient even without his consent. The recent trend of encouraging patients with learning disabilities to actively participate in decision making about their psychological and medical treatment raises even more complex questions regarding their ability to consent. How to take children’s consent to treatment? Children’s consent to treatment is one of the most important issues surrounding the complex area of consent to treatment. Conceptual and methodological issues continue to be debated in this grey area and the approach to the problem varies from country to country. 33-37 In general a child or young adolescent whose competence is in doubt will be found rational if he accepts the proposal to treatment but may be found incompetent if he disagrees to a medially indicated treatment. 38 Refusals of children or their parents to medically indicated treatment result in serious legal and ethical dilemmas putting the doctor in an embarrassing situation. Such situations demand careful and sensitive clinical and ethico-legal intervention and close cooperation among professionals particularly doctors and social workers.39 Professionals have to decide whichever legal route is best for a given child. In the UK , since the introduction of children act 1989 several cases have been brought on the issue of a child or young adolescent refusing to consent to a medically indicated treatment or assessment. 40-42 In the US, parents usually must consent to medical procedures involving minor children, however parental consent is not required in areas such as emergency situations, medical care in pregnancy, treatment of sexually transmitted diseases , treatment of substance abuse and experimental procedures. Moreover parents can’t withhold medical treatment when a child’s life is threatened by an illness or emergency. 18 We at our national level don’t have clear guidelines regarding the knotty issue of children’s consent to treatment and are blindly following what the Westerns are practicing. We need to enact essential legislation to avoid inconveniences which such issues pose to doctors from time to time. What is the ‘presumed consent’ to organ procurement from cadavers? Generally a person is considered to have a legitimate and primary proprietary in his or her living or dead body and thus has first right to control what happens to his or her body before and after death. 43 The concept of presumed consent has been popular in the transplant circles since 1968. 44 It has been given the status of law in Singapore in 1987 , stating that all majors are presumed to consent to organ donation if they don’t explicitly object to it . Muslim community of Singapore is generally considered objector unless they opt for it. For minors and mentally incapacitated people, consent is sought from next of kin. 45 This policy of presumed consent for organ procurement is certainly an attempt to allow for fulfillment of the needs of informed consent, however it is a highly complex issue requiring further work Ann. Pak. Inst. Med. Sci. 2006; 2(3):207-212 210
  • 5. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman particularly in our setup by close coordination among medical and legal professionals on one hand and religious scholars and public leaders on the other hand. How to tackle the consent issue in medical education, training and research in our setup? We have an interesting anecdote to share with our readers. It is rather a sort of personal experience which someone may enjoy as a joke but it really carries a great meaning in its depth. One of our final year MBBS clinical batches happened to examine an elderly male who presented with features of bladder outflow obstruction. Following his digital rectal examination by two students when a third one came forward , the patient stood up and said “I know you are all students but my anal canal is not your ‘madrassa’ “ This explicit display of the patient’s feelings is a real reflection of what exactly is happening in most of our teaching institutions whether undergraduate or postgraduate. Another equally important but ignored area is the medical research conducted on cognitively impaired human subjects. There is a dire need to evolve standardized approaches to such issues, which should not only safeguard the ethicolegal aspects from the patient’s perspective but also ensure proper training of the medical trainees. This need is all the greater owing to the fact that we are faced with ignorance, lack of awareness and lack of appropriate legal and professional guidelines appropriate to our own indigenous population and local circumstances. .Conclusion Informed consent is an indispensable component of contemporary medical and surgical practice. It not only ensures the patient’s autonomy, self-determination and informed decision-making but is also a reaffirmation of the doctor’s ethical and legal responsibilities towards his patient. In our set up the consent is taken for granted in the patients’ management. It is high time that this should be taken seriously. There is an urgent need for a properly designed study to look into the problems relating to the consent process and come up with clear guidelines that could be safely practiced by doctors in our community. 21) Edwards A, Elwyn G. Understanding risk and lessons for clinical risk communication about treatment preferences Qual Saf Health Care 2001; 10 (90001) : i9 - 13. References 1) Saaiq M, Zaman KU. Breaking bad news : How do we approach it ? Ann Pak Inst Med Sciences 2006 ; 2 (1) : 72-4. 2) Gendreau C. The rights of psychiatric patients in the light of the principles announced by the United Nations : a recognition of the right to consent to treatment. International Journal of Law and Psychiatry 1997; 20 : 259–78. 3) Department of Health and Welsh Office. Code of practice : Mental Health Act, 1983. London : HMSO, 1993. (UK legal document) 4) Kravitz RL , Melnikow J . Engaging patients in medical decision making . Br Med J ; 323 (7313 ): 584 - 5. 5) Frewer LJ , Salte B r , Lambert N. Understanding patients' preferences for treatment : the need for innovative methodologies Qual Saf Health Care 2001 ; 10 (90001 ) : i50 - 4. 6) Parikh CK. Consent . 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In: Bloch S, Chodoff P, Green SA, eds. Psychiatric ethics 3rd ed. Oxford : Oxford University Press, 1999 : 461–77. 16) Dickens B , Cook RJ. Dimensions of Informed Consent to Treatment . International Journal of Gynecology and Obstetrics 2004 ; 85: 309-314. 17) Singer PA, Choudhry S, Armstrong J. Public opinion regarding consent to treatment. J Am Geriatr Soc 1993 ; 41 (2 ): 112-6. 18) Fadem B. Legal and ethical issues in medical practice. In : High yield behavioural science. Maryland USA 1996 , Williams and Wilkins. 91-93. 19) Lloyd AJ. The extent of patients' understanding of the risk of treatments . Quality in Health Care 2001; 10 : i14-18. 20) Edwards A. Flexible rather than standardised approaches to communicating risks in health care. Qual Saf Health Care 2004 ; 13 (3) : 169 - 70. 22) Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent : why are its goals imperfectly realized ? N Engl J Med. 1980 ; 302 : 896-900. 23) Olver IN, Turrell SJ, Olszewski NA, Willson KJ. Impact of an information and consent form on patients having chemotherapy. Med J Aust. 1995; 162 (2 ) : 82-3. 24) Doak LG, Doak CC. Lowering the silent barriers to compliance for patients with low literacy skills. Promot Health. 1987 ; 8 (4) : 6-8. 25) Grisso T , Appelbaum PS. Assessing competence to consent to treatment . A Guide for Physicians and other Health Professionals. Ann. Pak. Inst. Med. Sci. 2006; 2(3):207-212 211
  • 6. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman Oxford University Press 1998 : 211 . 26) Staden C W V , Krüger CJ . Incapacity to give informed consent owing to mental disorder .Med Ethics 2003 ; 29 : 41-3. 27) Tepper AM, Elwork A. Competence to consent to treatment as a psycholegal construct . Law Human Behav 1984 ; 8 (3) : 205-23. 28) Law Commission. Mental incapacity. London : HMSO 1995. (Consultation paper no 231) (UK legal document) 29 ) Lord Chancellor's Department. Who decides? Making decisions on behalf of mentally incapacitated adults: a consultation paper. London: HMSO 1997. (UK legal document) 30) Lord High Chancellor. Making decisions: the government's proposals for making decisions on behalf of mentally incapacitated adults. London : The Stationery Office 1999. (Cmnd 4465.) (UK legal document) 31 ) Bursztajn HJ, Harding HP Jr, Gutheil TG, Brodsky A. Beyond cognition : the role of disordered affective states in impairing competence to consent to treatment. Bull Am Acad Psychiatry Law. 1991 ; 19 (4 ): 383-8. 32) Brahams D. Incompetent adults and consent to treatment. Lancet 1989 ; 1 (8633 ): 340. 33) Shields JM, Johnson A . Collision between law and ethics : consent for treatment with adolescents. Bull Am Acad Psychiatry Law. 1992 ; 20 (3 ): 309-23. 34) Devereux JA, Jones DP, Dickenson DL. Can children withhold consent to treatment? Br Med J 1993 ; 306 (6890 ): 1459-61. 35) Brooks WG , Bahar-Posey L, Weathers L, Pardue W. Children's consent to treatment . Br Med J 1994 ; 807-9. 36) Shield JPH, Baum JD. Children's consent to treatment. Br Med J 1994 ; 308 :1182-3. 37) Korin JB. Legal aspects of emergency department paediatrics. In: Ludwig S, Fleisher GR. Textbook of paediatric emergency medicine. 3rd ed. Baltimore: Williams and Wilkins, 1993 : 1559. 38) Gellis SS . Children's informed consent to treatment ? Pediatric Notes 1994 ; 18 (24) : 1. 39) Elton A, Honig P, Bentovim A, Simons J . Withholding consent to lifesaving treatment : three cases . Br Med J 1995 ; 310 : 373-77 . 40) Re R [1991] 3 WLR 592-608. (UK legal document) 41) Re W [1992] 3 WLR 758-82. (UK legal document) 42) South Glamorgan County Council v W and B [1993] 1 FLR 574-86. (UK legal document) 43) Peter DA. Protecting autonomy in organ procurement procedures : some overlooked issues. Milbank Q 1986 ; 64(2) : 241-70. 44) Dukeminier J Jr, Sanders D. Organ transplantation : a proposal for routine salvaging of cadaver organs. N Engl J Med 1968 ; 279 : 413- 9. 45) Teo B. Organs for transplantation : The Singapore experience. Hastings Cent Rep 1991 ; 21 (6) :10-3. Ann. Pak. Inst. Med. Sci. 2006; 2(3):207-212 212

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