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ORIGINAL ARTICLE  
Year : 2012  |  Volume : 2  |  Issue : 1  |  Page : 25-27
A cross sectional study of the patient's awareness and understanding toward legal nature of informed consent in a dental hospital in rural Haryana


1 Department of Community Medicine, MMIMSR, Mullana - Ambala, India
2 Department of Community Dentistry, MMIDS, Mullana, India
3 Department of Community Medicine, KMC, Mangalore, India
4 Department of OBG, MM Institute of Nursing, Mullana, India
5 Department of Forensic Medicine, MMIMSR, Mullana, Haryana, India

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Date of Web Publication17-Jul-2013
 

   Abstract 

Aims: The objective of this study is to define the patient's awareness of legal issues, attitude toward consent process. An additional objective of this study is to find out whether or not the patients actually understand what has been explained to them.
Materials and Methods: The present cross-sectional study was carried out during January 2011 to July 2011 at a tertiary care dental hospital. In this study, a structured interview schedule was developed and handed out to 582 patients in the various outpatient departments of the hospital. SPSS version 11.5 was used for analysis.
Results: Of the 582 patients approached, 58 patients refused to participate and interviewed 524 patients. Most (88.0%) of the patients under study thought that they had no right to change their minds after signing the consent. A total of 75% patients falsely believed that it was a legal requirement. Overall the level of understanding was poor in 17%, unsatisfactory in 33%, satisfactory in 32%, and good in 18% of the patients. The level of understanding was significantly associated with educational level (P < 0.01).
Conclusion: There exists a vast discrepancy between the informed consents perceived by patients. Limited knowledge of the legal implications of signing or not signing consent form indicates that consent process should be reassessed in order to achieve patient autonomy.

Keywords: Informed consent, legal aspects, patient, rural

How to cite this article:
Singh A, Bhardwaj A, Jindal R, Mithra P, Siddique A, Rajesh D R. A cross sectional study of the patient's awareness and understanding toward legal nature of informed consent in a dental hospital in rural Haryana. J Educ Ethics Dent 2012;2:25-7

How to cite this URL:
Singh A, Bhardwaj A, Jindal R, Mithra P, Siddique A, Rajesh D R. A cross sectional study of the patient's awareness and understanding toward legal nature of informed consent in a dental hospital in rural Haryana. J Educ Ethics Dent [serial online] 2012 [cited 2020 Apr 7];2:25-7. Available from: http://www.jeed.in/text.asp?2012/2/1/25/115147



   Introduction Top


Autonomy of patients is an imperative 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 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]

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],[4] 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. [5] Hence the present study was undertaken with the objective of defining the patient's awareness of legal issues, attitude toward consent. Additional objective of this study was to find out whether or not the patients actually understand what has been explained to them.


   Materials and Methods Top


The present observational cross-sectional study was carried out in the Oral and Maxillofacial Surgery department during January 2011 to July 2011 at a tertiary care dental teaching hospital at northern India. Information was collected by interviewing the patients using a structured interview schedule. The survey was done by a single surgical resident. However, if the surveyor himself did the preoperative counseling, that particular patient was excluded. The purpose and nature of the study were explained to the patients verbally and they were requested to participate in the study. In this study a structured interview schedule was developed and handed out to 582 patients in the various outpatient departments (OPDs) of the hospital who had come to seek care and signed their consent forms. The interview schedule was given to 10 such patients initially for pilot testing. The final interview schedule was developed after a few modifications in the questions.

A detailed proforma was prepared for the purpose of recording the socio-demographic profile of patients and extracting information regarding awareness, attitude, and understanding toward 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. Five questions were framed and points were allocated to their answers. Questions asked were regarding the disease for which the patient was admitted, about the surgical procedure, information about anesthesia, pain control, and recurrence and post-op measures. 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 the 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.

For the purpose of study, a literate person was defined as any person who can read and write with understanding in any language. Primary educated patients completed schooling till fifth standard. Patients were categorized educated if they completed education beyond fifth standard.

The collected data were entered in Microsoft Excel. Coding of the variables was done. SPSS version 11.5 was used for analysis. Interpretation of the collected data was done by using appropriate statistical methods like percentage and proportions. A Chi-square test was applied to test for proportions wherever applicable.


   Results Top


Of the 582 patients approached, 58 patients refused to participate and 524 patients interviewed. Out of total, 24 interviews were discarded during data analysis due to lack of internal consistency. Average age of patients was 42.5 ± 10.6 years. Majority (63.2%) of the patients were in the age group of 31-50 years. A total of 81.6% of the patients were males; 31.02% of the victims had a primary level of education while 20.27% of the victims were illiterates.

Patient's awareness and understanding toward 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. A total of 83.8% signed the consent form so that they can undergo required operative procedure [Table 1].
Table 1: Distribution of subjects according to the patient's awareness, attitude, and understanding toward consent and its legal issues

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Patient's understanding to what has been explained to them

The level of understanding was similar in males and females (53.6% in males and 52.6% in females, 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 < 0.01). Looking at the values the level of understanding is not different between those who had a primary level of education and those who did not had formal education but it was significantly better in those who had higher education.

Overall the level of understanding was poor in 17%, unsatisfactory in 33%, satisfactory in 32%, and good in 18% of the patients.


   Discussion Top


Although patients want to know their legal rights in hospital but their awareness of legal and ethical issues related to the consent process is often limited. Adequate information before a surgical procedure is fundamental to give informed consent. Information should include a description of the benefits, risks, and complications of the intended procedure as well as alternative treatment options. [6]

Several studies have shown that written information has beneficial effects. Patients who were given written information have better understanding and postoperative recall of information. [7],[8]

The present study revealed that 75.0% patients falsely believed that it was a legal requirement. A total of 68.8% thought that signing the consent meant waving their rights to any compensation. Most (88.0%) of the patients thought that they had no right to change their minds after signing the consent. Similar observations were also made by another study from Egypt. [9]

It was found in this study that majority of the patients were interested to know about duration of the operation, possible risks and complications involved if they undergo the operation, chances of successful operation, and cost of treatment. Our findings confirm the results of another study from New Zealand. [10]

Not surprisingly our study shows that many patients have limited knowledge of the legal implications of signing or not signing consent forms and do not recognize written consent as primarily serving their interests. Similar observations were also made by Akkad. [11]


   Conclusion Top


The study concludes that there exists a vast discrepancy between the informed consents perceived by patients; hence current consent procedures seem inadequate. The difference in perception and limited knowledge of the legal implications of signing or not signing consent form indicates that consenting in its current form is not informed and should be reassessed in order to achieve patient autonomy.


   Acknowledgment Top


We would like to thank Dr. Pradeep Singh, Dr. Pankaj Chikkara, Dr. Kuldeep Singh and Dr. Sanjeet Panesar for their keen interest and constant support throughout the study. We are indebted to all team members who worked with us in this investigation.

 
   References Top

1.Bhurgri H, Qidwai W. Awareness of the process of informed consent among family practice patients in Karachi. J Pak Med Assoc 2004;54:398-401.  Back to cited text no. 1
[PUBMED]    
2.Beauchamp TL, Childress JF. The principles of biomedical ethics. 4 th ed. New York: Oxford University Press; 2001.  Back to cited text no. 2
    
3.Informed consent in health and social care research, RCN guidance for nurses. 4 th ed. London: Royal College of Nursing Research Society; 2011.  Back to cited text no. 3
    
4.Guillod O. Pour une meilleure information des patients: Des brochures écrites. Schweiz Arzteztg 1995;76:318-21.  Back to cited text no. 4
    
5.Doyal L. Good clinical practice and informed consent are inseparable. Heart 2002;87:103-5.  Back to cited text no. 5
[PUBMED]    
6.Bates T. Ethics of consent to surgical treatment. Br J Surg 2001;88:1283-4.  Back to cited text no. 6
[PUBMED]    
7.Askew G, Pearson KW, Cryer D. Informed consent: Can we educate patients? J R Coll Surg Edinb 1990;35:308-10.  Back to cited text no. 7
[PUBMED]    
8.Lewis PJ, O'Keefe L, Adcock S. Patients who were given information sheets have better postoperative recall of information [letter]. J R Coll Surg Edinb 1991;36:206-7.  Back to cited text no. 8
[PUBMED]    
9.Ahmed SA, Dewedar S. Obstetric patient perceptions of written consent forms: A middle east hospital study. Int J Acad Res 2011;3:471-5.  Back to cited text no. 9
    
10.Newton HP, Bedford ND, Dobbs BR, Frizelle FA. Informed consent: What do patients want to know? N Z Med J 1998;111:340-2.  Back to cited text no. 10
    
11.Akkad A, Jackson C, Kenyon S, Woods MD, Taub N, Habiba M. Patients' perceptions of written consent: Questionnaire study. BMJ 2006;333:528-9.  Back to cited text no. 11
    

Top
Correspondence Address:
Abhishek Singh
Department of Community Medicine, Maharishi Markandeshwar Institute of Medical Sciences, Mullana - Ambala, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7761.115147

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    Abstract
   Introduction
    Materials and Me...
   Results
   Discussion
   Conclusion
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    References
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