jiafm-35-1 - forensic medicine

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J Indian Acad Forensic Med. Jan-March 2013, Vol. <strong>35</strong>, No. 1 ISSN 0971-0973 Original Research Paper Patient’s Awareness, Attitude, Understanding and Perceptions towards Legal Nature of Informed Consent *Rajesh DR, **Abhishek Singh, *Mukul Chopra, *Gaurav P Singh, *Venkteshan M, ***Anu Bhardwaj, ****Balbir Kaur, *****OP Aggarwal Abstract Patient’s autonomy is an imperative issue in the health service area. It is a known fact that patient’s awareness of legal and ethical issues related to the consent process is often limited. The present study was therefore conducted to ascertain patient’s awareness, attitude and perceptions towards Legal nature of informed consent. A structured interview schedule was developed and handed out to 555 patients in the Surgery department during January 2011 to June 2011. A great deal of misconception regarding the legal status of consent was seen. 88% of participants believed that they had no right to change their mind after signing the consent. 61.6% trusted their doctor to do the right thing and did not mind what happened to them provided they were made better. Level of understanding was satisfactory in only 32% of patients. The study concludes that there exists a vast discrepancy between the informed consent that perceived by patients. Current consent procedures seem inadequate as a means for the expression of autonomous choice and their ethical standing can be called into question. Key Words: Informed consent, Legal, Education level, Patients’ Rights Introduction: Autonomy of patients is an important issue in the health service area. Informed consent is an autonomous action by a subject or patient that authorizes a professional either to involve the subject in research or to initiate a medical plan for the patient. [1] It is the fundamental mechanism whereby the physician informs the patient about the options for the diagnosis and treatment of the patient's illness. It is not just a form to be signed as a hospital formality, but a process, which ensures respect for persons through provision of thoughtful consent for an option to decide on the best possible treatment in disease processes, so that the patient can make a rational voluntary decision regarding what he/she wants to be done. [1, 2] Corresponding Author: *Resident, Department of Forensic Medicine and Toxicology MMISMS&R Mullana, Ambala 133207 E-mail: rajeshdd86@gmail.com **Resident, Dept. of Community Medicine *Resident, Dept. of FMT ***Associate Prof, Dept. of Community Medicine. ****Prof, Dept. of FMT ****Prof & Head, Dept. of FMT DOR:31.7.12 DOA:8.2.13 Informed consent is the process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means in particular, in terms of harms and benefits. [3] Informed Consent originates from the legal and ethical rights of the patient have to direct what happens to his/her body and from the ethical duty of the physician to involve the patient in his/her health care. The most important goal of informed consent is that the patient should have an opportunity to be an informed participant in his health care decisions so it acts as a safeguard to ensure the preservation of individual rights. [1] Patients often feel powerless and vulnerable and it is a proven fact that patient’s awareness of legal and ethical issues related to the consent process is often limited. The informed consent process should be seen as an invitation to him to participate in his health care decisions. The objective of this study is to define patient’s awareness of legal issues, attitude towards consent. Additional objective of this study is to determine what patients want to know and to find out whether or not the patients actually understand what has been explained to them. Materials and Methods: The present observational cross sectional study was carried out in the Surgery Department between January 2011 to June 40
J Indian Acad Forensic Med. Jan-March 2013, Vol. <strong>35</strong>, No. 1 ISSN 0971-0973 2011 at Maharishi Markandeshwar Institute of Medical Sciences and Research (MMIMSR), Mullana (Ambala). Information was collected by interviewing the patients using a structured interview schedule. In this study a structured interview schedule was developed and handed out to 555 patients in the Surgery department of the hospital who had just undergone surgery and who were counseled before their elective surgery and signed their consent forms. Interview schedule was given to 10 such patients initially for pilot testing. Final interview schedule was developed after a few modifications in the questions. A detailed proforma for the purpose of recording socio-demographic profile of patients, extracting information regarding awareness, attitude & understanding towards informed consent and their legal issues. A few questions were framed to determine what patients want to know. To access patients understanding to what has been explained to them, a score was calculated. 5 questions were framed and points were allocated to their answers; 5 points if they understood well, 3 if they had some understanding and 0 if they had no understanding. The points were added to give their total points. If patient obtained a score of less than 25% of the total score, he/she was said to have a poor understanding. Similarly, a score of 25- 49% was judged as unsatisfactory; 50 -74% as satisfactory and any score of 75% or above was judged to be good. The collected data were Coded and SPSS version 11.5 was used for analysis. Interpretation of the collected data was done by using appropriate statistical methods. lChi-square test was applied to test for proportions wherever applicable. Observations & Results: Of the 555 patients approached, 31 patients refused to participate and interviewed 524 patients. The response rate was 94.41%. Out of total, 24 interviews were discarded during data analysis due to lack of internal consistency. The mean age was 41 years. (A) Patient’s awareness, attitude & understanding towards consent and their legal issues: Despite the legal importance of the consent and its presence in the signed documents as a standard procedure yet 75.0% patients falsely believed that it was a legal requirement. An almost similar percentage of respondents (68.8%) thought that signing the consent meant waving their rights to any compensation. Most (88.0%) of the patients under study thought that they had no right to change their minds after signing the consent. Many of the patients (75.2%) believed that they would be left to die hadn’t they signed the consent. 83.8% signed the consent form so that they can undergo required operative procedure. (Table1) (B) What do patients really want to know about their treatment Most of the patients were interested to know about duration of the operation, possible risks & complications involved if they undergo the operation, chances of successful operation and cost of treatment. 63.6% were not bothered to know what will be done during the operation provided they were made better. (Table 2) (C) Role of patients in decision making about the treatment: Most (69.2%) of the patients were happy to allow doctors to determine their treatment but they wanted to know about their condition, the treatment and the important side effects. Only a few patients (11.6%) wanted to make final decision themselves. 61.6% trusted their doctor to do the right thing and did not think detailed explanation was important. (Table 3) (D) Patient’s skill to understand to what has been explained to them: The level of understanding was similar in male and female (53.6% in male and 52.6% in female, p >0.05). According to the level of education, those who were illiterate had a mean score of 44.6%, those who had primary education only had a mean score of 46.6% and those who were educated had a mean score of 68.2% (p
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