Nursing Ethics http://nej.sagepub.com/ Surgical informed consent in Iran−−how much is it informed? Somayeh Faghanipour, Soodabeh Joolaee and Marzieh Sobhani Nurs Ethics 2014 21: 314 originally published online 21 October 2013 DOI: 10.1177/0969733013498525 The online version of this article can be found at: http://nej.sagepub.com/content/21/3/314
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Article
Surgical informed consent in Iran—how much is it informed?
Nursing Ethics 2014, Vol. 21(3) 314–322 ª The Author(s) 2013 Reprints and permission: sagepub.co.uk/journalsPermissions.nav 10.1177/0969733013498525 nej.sagepub.com
Somayeh Faghanipour Centre for Biomedical Ethics and Law, KU Leuven, Belgium
Soodabeh Joolaee Tehran University of Medical Sciences, Iran
Marzieh Sobhani Isfahan University of Medical Sciences, Iran
Abstract Introduction: Informed consent constitutes one of the most important legal, professional, and ethical principles of a surgical operation. Consent obtained from a patient is only valid when the patient has received enough information regarding the proposed treatment option. This study aims to determine how much the patients are informed before undergoing surgery, as well as the factors influencing it in hospitals affiliated with Tehran University of Medical Sciences. Method: This is a cross-sectional, descriptive–analytic study of 300 patients undergoing surgery in 7 teaching hospitals affiliated with Tehran University of Medical Sciences. The patients were recruited through clustered sampling. Data were collected using a questionnaire completed by interview. Data were analyzed on SPSS software using descriptive and inferential statistics. Result: The mean score of data provision for patients was 27.09 out of 60, indicating the level of information provided as unacceptable. Among 12 questions dealing with data provision, patients had received an intermediate level of information about nature of the disease, type of surgery, benefits and importance of the surgery, and complications of rejecting the recommended therapy. On the contrary, they had not received enough information about the surgical procedure, type of anesthesia, potential complications of surgery, potential risks of surgery, other therapy options instead of surgery, length of hospital stay for surgery, postsurgical follow-up, and expenses of the surgery. In the majority (85%) of cases, the surgeon was reported to be the information provider. Among the variables studied, level of information received was directly related to the patient’s education level. Discussion: The findings of this study indicate that during the process of obtaining an informed consent for surgery, patients do not receive sufficient information, and it is necessary to provide the essential information in an understandable manner adjusted for the patient’s level of education. Keywords Information, informed consent, surgery
Corresponding author: Soodabeh Joolaee, Nursing and Midwifery School, Center for Nursing Care Research, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., PO Box 1419733171, Tehran, Iran. Email: [email protected]
Downloaded from nej.sagepub.com at GEORGIAN COURT UNIV on October 2, 2014
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Introduction Although surgical procedures are a routine subject for surgeons and hospital personnel, they are a novel experience for patients who undergo surgery. As most surgical procedures are quite sophisticated, their risks and benefits are unclear for patients, presenting them with a dilemma in many cases. For this reason, patients nominated for surgery require information and guidance about their disease, therapy options, the mechanisms of the surgical procedure, its benefits and drawbacks, and alternative therapy options.1 Informed consent is an essential mechanism to ensure that patients have received the necessary information to guarantee patient involvement in treatment and shared decision making and to help them make an autonomous and informed decision.2 The term ‘‘consent’’ reflects the patient’s autonomy and independence, indicating that the patient may choose to accept or reject the proposed therapy, even if its rejection should entail serious risks. The epithet ‘‘informed’’ highlights the fact that the decision is made based on information provided for the patients and the questions answered.3 Involving the patients in decisions concerning themselves will contribute to the treatment process.4 Previous studies indicate a relationship between appropriate informed consent and favorable clinical outcomes including improved mental health, resolution of symptoms and pain, improved patient collaboration, and improved physiologic parameters. It also enhances the patient’s compliance with medications as well as his or her satisfaction.5,6 For this purpose, the surgeon is responsible for delivering the information regarding the diagnostic or therapeutic procedure clearly, precisely, unambiguously, and in a fashion understandable for the patients or their representatives in order to clarify the available therapy options, each with its potential benefits and risks.7 Nevertheless, it is often observed that surgeons tend to refrain from long talks with patients due to their busy schedule or other factors, and some studies even indicate that some surgeons provide incorrect information for patients.1 Another challenge is the fact that the technical terminology used by surgeons and other healthcare personnel or cultural and linguistic barriers make them incomprehensible to patients, thus limiting the information received by patients. Despite the pivotal role of consent in medical ethics and the consensus of previous studies on the fact that consent from patients must necessarily be informed, it is often observed that the major component of an informed consent, that is, provision of information, is neglected.2 The term ‘‘informed consent’’ is usually reminiscent of a long sheet presented to the patient’s representative on admission or behind the doors of the operating room. Another suggestion of the term is the measure taken by a cautious surgeon to relinquish legal liability and avoid future legal troubles.6 Very few studies have been conducted in Iran to deal with this issue. One study on 300 patients undergoing surgery in teaching hospitals of Kashan reported an unfavorable level of information provided for patients. In that study, more than 50% of patients believed that they had not been informed about the complications and length of stay, and more than 60% stated that they had been given no information regarding other therapy alternatives and the follow-up after discharge.7 In a Nigerian study by Ogundiran and Adebamowo,8 54.9% of physicians believed that they do not provide enough information for their patients when obtaining an informed consent for surgery. On the contrary, a Turkish study reported that more than half of the patients were satisfied with the information provided for them before surgery.9 Similarly, a Korean study reported that 91.8% of physicians stated they spent enough time to inform their patients, 89% of patients stated they had received enough information about the details of surgery, and 94% stated that the risks and complications of surgery had been explained to them.10 In general, previous studies indicate some shortcomings in the process of obtaining informed consent for surgeries which disregard the legal and ethical standards of patient care as soon as they are admitted to the hospital. However, identifying which aspects of an informed consent are more neglected will help improve the process of providing information to patients. As Tehran is the medical center of Iran, and in addition to patients residing in Tehran, many others are referred from other cities to undergo surgery there,11 we conducted this study in Tehran. The 315
Downloaded from nej.sagepub.com at GEORGIAN COURT UNIV on October 2, 2014
316
Nursing Ethics 21(3)
objective of the study is to investigate information provision to patients before surgery as part of their informed consent and its associated factors in hospitals affiliated with Tehran University of Medical Sciences.
Method This is a cross-sectional, descriptive–analytic study aiming to investigate information provision to patients before surgery as part of their informed consent and its associated factors. The study population consisted of 300 patients undergoing surgery in selected hospitals affiliated with Tehran University of Medical Sciences. The hospitals were selected through multistage clustered sampling with proportional allocation. The study environment included 7 selected hospitals affiliated with Tehran University of Medical Sciences, chosen out of 24 teaching hospitals with elimination of psychiatric and pediatric hospitals and using a table of randomized numbers. Subsequently, the number of beds in each hospital served as the basis for allocating the appropriate number of patients selected from that hospital. We referred to the hospitals on morning and evening shifts and recruited eligible patients willing to participate in our study from different surgical wards. The inclusion criteria were age over 18 years, lack of mental disorders or any other condition compromising the patient’s judgment, and willingness to participate in the study. The study proposal was approved by the Ethics Committee at Tehran University of Medical Sciences. All participants expressed their informed consent in writing. The patients were reassured about the anonymity of their information and the fact that their responses will have no bearing on their treatment. Data were collected using a questionnaire completed by interview. Since in some cases the patients are provided with the information about their surgery following admission to the hospital ward and prior to surgery, by collecting data prior to surgery, we may miss some information which has been provided to the patients between the completion of questionnaire and surgery, and therefore, we questioned the patients 1–3 days after surgery. The questionnaire consisted of a general and a specific section. The former inquired about the patient’s personal characteristics (age, sex, number of admissions, level of education, residence, and type of surgery). The specific section consisted of 15 questions, 13 of which were designed using a Likert scale. The final two questions were multiple-choice questions using a different scale. These questions dealt with ‘‘the person providing the information’’ and ‘‘the time the information was provided.’’ This tool measured the amount of information provided using the Likert scale as follows: Not at all ¼ 0; Very deficiently ¼ 1; Deficiently ¼ 2; To some extent ¼ 3; Completely ¼ 4; and Very completely ¼ 5. The score ranged from 0 to 60, with higher scores indicating a greater amount of information received. In general, scores below 50% (scores under 30) were deemed unacceptable, 50%–75% (score of 30–45) were deemed intermediate, and more than 75% (score over 45) were deemed acceptable. The instrument was developed after consulting the relevant literature, and we determined the content and face validity of our questionnaire by asking four experts in medical ethics and six faculty members to review and comment on the questionnaire; we gave them a preliminary version of a self-designed questionnaire and a paper containing general and specific objectives of our study and asked them to comment on the questionnaire according to our study objectives and specify the ambiguities and linguistic errors; their suggestions were used to revise the questionnaire. In order to determine the reliability of the questionnaire, we used internal reliability in the following manner: the questionnaire was first completed by 20 study participants. The value of Cronbach’s alpha calculated with this method (0.85) confirmed the reliability of our questionnaire. Data were analyzed on SPSS version 16 using descriptive statistics including frequency, mean and standard deviation, and inferential statistics including w2, Spearman’s, and Pearson’s correlation coefficient. 316
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Table 1. Basic information of patients studied and the relationship with amount of information received. Basic information Age (years) 18–40 41–62 63–82 Sex Male Female Number of admissions Once Twice 3 times 4 times 5 times 6 times and more Education level Illiterate Elementary school High school College Bachelor’s Master’s and higher Residency Tehran Other Type of surgery General Special
Number (%)
Relationship between information received and basic information (P value)
140 (46.7) 123 (41) 37 (12.3)
0.74
146 (48.7) 154 (51)
0.17
92 (30.7) 70 (23.3) 85 (26.7) 20 (8.7) 26 (8.7) 12 (4) 64 (21.3) 150 (50) 53 (17.7) 13 (4.3) 18 (6) 2 (7)
0.17
Published by: http://www.sagepublications.com
Additional services and information for Nursing Ethics can be found at: Email Alerts: http://nej.sagepub.com/cgi/alerts Subscriptions: http://nej.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav Citations: http://nej.sagepub.com/content/21/3/314.refs.html
>> Version of Record - Apr 30, 2014 OnlineFirst Version of Record - Oct 21, 2013 What is This?
Downloaded from nej.sagepub.com at GEORGIAN COURT UNIV on October 2, 2014
Article
Surgical informed consent in Iran—how much is it informed?
Nursing Ethics 2014, Vol. 21(3) 314–322 ª The Author(s) 2013 Reprints and permission: sagepub.co.uk/journalsPermissions.nav 10.1177/0969733013498525 nej.sagepub.com
Somayeh Faghanipour Centre for Biomedical Ethics and Law, KU Leuven, Belgium
Soodabeh Joolaee Tehran University of Medical Sciences, Iran
Marzieh Sobhani Isfahan University of Medical Sciences, Iran
Abstract Introduction: Informed consent constitutes one of the most important legal, professional, and ethical principles of a surgical operation. Consent obtained from a patient is only valid when the patient has received enough information regarding the proposed treatment option. This study aims to determine how much the patients are informed before undergoing surgery, as well as the factors influencing it in hospitals affiliated with Tehran University of Medical Sciences. Method: This is a cross-sectional, descriptive–analytic study of 300 patients undergoing surgery in 7 teaching hospitals affiliated with Tehran University of Medical Sciences. The patients were recruited through clustered sampling. Data were collected using a questionnaire completed by interview. Data were analyzed on SPSS software using descriptive and inferential statistics. Result: The mean score of data provision for patients was 27.09 out of 60, indicating the level of information provided as unacceptable. Among 12 questions dealing with data provision, patients had received an intermediate level of information about nature of the disease, type of surgery, benefits and importance of the surgery, and complications of rejecting the recommended therapy. On the contrary, they had not received enough information about the surgical procedure, type of anesthesia, potential complications of surgery, potential risks of surgery, other therapy options instead of surgery, length of hospital stay for surgery, postsurgical follow-up, and expenses of the surgery. In the majority (85%) of cases, the surgeon was reported to be the information provider. Among the variables studied, level of information received was directly related to the patient’s education level. Discussion: The findings of this study indicate that during the process of obtaining an informed consent for surgery, patients do not receive sufficient information, and it is necessary to provide the essential information in an understandable manner adjusted for the patient’s level of education. Keywords Information, informed consent, surgery
Corresponding author: Soodabeh Joolaee, Nursing and Midwifery School, Center for Nursing Care Research, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., PO Box 1419733171, Tehran, Iran. Email: [email protected]
Downloaded from nej.sagepub.com at GEORGIAN COURT UNIV on October 2, 2014
Faghanipour et al.
315
Introduction Although surgical procedures are a routine subject for surgeons and hospital personnel, they are a novel experience for patients who undergo surgery. As most surgical procedures are quite sophisticated, their risks and benefits are unclear for patients, presenting them with a dilemma in many cases. For this reason, patients nominated for surgery require information and guidance about their disease, therapy options, the mechanisms of the surgical procedure, its benefits and drawbacks, and alternative therapy options.1 Informed consent is an essential mechanism to ensure that patients have received the necessary information to guarantee patient involvement in treatment and shared decision making and to help them make an autonomous and informed decision.2 The term ‘‘consent’’ reflects the patient’s autonomy and independence, indicating that the patient may choose to accept or reject the proposed therapy, even if its rejection should entail serious risks. The epithet ‘‘informed’’ highlights the fact that the decision is made based on information provided for the patients and the questions answered.3 Involving the patients in decisions concerning themselves will contribute to the treatment process.4 Previous studies indicate a relationship between appropriate informed consent and favorable clinical outcomes including improved mental health, resolution of symptoms and pain, improved patient collaboration, and improved physiologic parameters. It also enhances the patient’s compliance with medications as well as his or her satisfaction.5,6 For this purpose, the surgeon is responsible for delivering the information regarding the diagnostic or therapeutic procedure clearly, precisely, unambiguously, and in a fashion understandable for the patients or their representatives in order to clarify the available therapy options, each with its potential benefits and risks.7 Nevertheless, it is often observed that surgeons tend to refrain from long talks with patients due to their busy schedule or other factors, and some studies even indicate that some surgeons provide incorrect information for patients.1 Another challenge is the fact that the technical terminology used by surgeons and other healthcare personnel or cultural and linguistic barriers make them incomprehensible to patients, thus limiting the information received by patients. Despite the pivotal role of consent in medical ethics and the consensus of previous studies on the fact that consent from patients must necessarily be informed, it is often observed that the major component of an informed consent, that is, provision of information, is neglected.2 The term ‘‘informed consent’’ is usually reminiscent of a long sheet presented to the patient’s representative on admission or behind the doors of the operating room. Another suggestion of the term is the measure taken by a cautious surgeon to relinquish legal liability and avoid future legal troubles.6 Very few studies have been conducted in Iran to deal with this issue. One study on 300 patients undergoing surgery in teaching hospitals of Kashan reported an unfavorable level of information provided for patients. In that study, more than 50% of patients believed that they had not been informed about the complications and length of stay, and more than 60% stated that they had been given no information regarding other therapy alternatives and the follow-up after discharge.7 In a Nigerian study by Ogundiran and Adebamowo,8 54.9% of physicians believed that they do not provide enough information for their patients when obtaining an informed consent for surgery. On the contrary, a Turkish study reported that more than half of the patients were satisfied with the information provided for them before surgery.9 Similarly, a Korean study reported that 91.8% of physicians stated they spent enough time to inform their patients, 89% of patients stated they had received enough information about the details of surgery, and 94% stated that the risks and complications of surgery had been explained to them.10 In general, previous studies indicate some shortcomings in the process of obtaining informed consent for surgeries which disregard the legal and ethical standards of patient care as soon as they are admitted to the hospital. However, identifying which aspects of an informed consent are more neglected will help improve the process of providing information to patients. As Tehran is the medical center of Iran, and in addition to patients residing in Tehran, many others are referred from other cities to undergo surgery there,11 we conducted this study in Tehran. The 315
Downloaded from nej.sagepub.com at GEORGIAN COURT UNIV on October 2, 2014
316
Nursing Ethics 21(3)
objective of the study is to investigate information provision to patients before surgery as part of their informed consent and its associated factors in hospitals affiliated with Tehran University of Medical Sciences.
Method This is a cross-sectional, descriptive–analytic study aiming to investigate information provision to patients before surgery as part of their informed consent and its associated factors. The study population consisted of 300 patients undergoing surgery in selected hospitals affiliated with Tehran University of Medical Sciences. The hospitals were selected through multistage clustered sampling with proportional allocation. The study environment included 7 selected hospitals affiliated with Tehran University of Medical Sciences, chosen out of 24 teaching hospitals with elimination of psychiatric and pediatric hospitals and using a table of randomized numbers. Subsequently, the number of beds in each hospital served as the basis for allocating the appropriate number of patients selected from that hospital. We referred to the hospitals on morning and evening shifts and recruited eligible patients willing to participate in our study from different surgical wards. The inclusion criteria were age over 18 years, lack of mental disorders or any other condition compromising the patient’s judgment, and willingness to participate in the study. The study proposal was approved by the Ethics Committee at Tehran University of Medical Sciences. All participants expressed their informed consent in writing. The patients were reassured about the anonymity of their information and the fact that their responses will have no bearing on their treatment. Data were collected using a questionnaire completed by interview. Since in some cases the patients are provided with the information about their surgery following admission to the hospital ward and prior to surgery, by collecting data prior to surgery, we may miss some information which has been provided to the patients between the completion of questionnaire and surgery, and therefore, we questioned the patients 1–3 days after surgery. The questionnaire consisted of a general and a specific section. The former inquired about the patient’s personal characteristics (age, sex, number of admissions, level of education, residence, and type of surgery). The specific section consisted of 15 questions, 13 of which were designed using a Likert scale. The final two questions were multiple-choice questions using a different scale. These questions dealt with ‘‘the person providing the information’’ and ‘‘the time the information was provided.’’ This tool measured the amount of information provided using the Likert scale as follows: Not at all ¼ 0; Very deficiently ¼ 1; Deficiently ¼ 2; To some extent ¼ 3; Completely ¼ 4; and Very completely ¼ 5. The score ranged from 0 to 60, with higher scores indicating a greater amount of information received. In general, scores below 50% (scores under 30) were deemed unacceptable, 50%–75% (score of 30–45) were deemed intermediate, and more than 75% (score over 45) were deemed acceptable. The instrument was developed after consulting the relevant literature, and we determined the content and face validity of our questionnaire by asking four experts in medical ethics and six faculty members to review and comment on the questionnaire; we gave them a preliminary version of a self-designed questionnaire and a paper containing general and specific objectives of our study and asked them to comment on the questionnaire according to our study objectives and specify the ambiguities and linguistic errors; their suggestions were used to revise the questionnaire. In order to determine the reliability of the questionnaire, we used internal reliability in the following manner: the questionnaire was first completed by 20 study participants. The value of Cronbach’s alpha calculated with this method (0.85) confirmed the reliability of our questionnaire. Data were analyzed on SPSS version 16 using descriptive statistics including frequency, mean and standard deviation, and inferential statistics including w2, Spearman’s, and Pearson’s correlation coefficient. 316
Downloaded from nej.sagepub.com at GEORGIAN COURT UNIV on October 2, 2014
Faghanipour et al.
317
Table 1. Basic information of patients studied and the relationship with amount of information received. Basic information Age (years) 18–40 41–62 63–82 Sex Male Female Number of admissions Once Twice 3 times 4 times 5 times 6 times and more Education level Illiterate Elementary school High school College Bachelor’s Master’s and higher Residency Tehran Other Type of surgery General Special
Number (%)
Relationship between information received and basic information (P value)
140 (46.7) 123 (41) 37 (12.3)
0.74
146 (48.7) 154 (51)
0.17
92 (30.7) 70 (23.3) 85 (26.7) 20 (8.7) 26 (8.7) 12 (4) 64 (21.3) 150 (50) 53 (17.7) 13 (4.3) 18 (6) 2 (7)
0.17
