Original Manuscript
The quality of obtaining surgical informed consent: Case study in Iran
Nursing Ethics 1–10 ª The Author(s) 2015 Reprints and permission: sagepub.co.uk/journalsPermissions.nav 10.1177/0969733015584398 nej.sagepub.com
Soodabeh Joolaee Iran University of Medical Sciences, Iran; University of British Colombia, Canada
Somayeh Faghanipour University of Toronto, Canada
Fatemeh Hajibabaee Tehran University of Medical Sciences, Iran
Abstract Background: Informed consent goes beyond signing a form; it is a process of providing necessary information, helping patients make an informed decision, and actively participate in their treatment. Aim/objective: This study aimed to assess the quality of obtaining surgical informed consent in hospitals affiliated with Tehran University of Medical Sciences. Research design/participants/context: In a cross-sectional, descriptive-analytical study, 300 patients were chosen through stratified sampling from seven hospitals affiliated with Tehran University of Medical Sciences. Data were collected using a questionnaire developed by the researchers and analyzed using descriptive and analytical statistics on SPSS software. Ethical considerations: Ethical approval of this study was granted by Tehran University of Medical Sciences research ethics committee. Written informed consent for participation was obtained. The participants were reassured that their information will be used anonymously and their answers will not affect their treatment and care. Findings: The mean score of quality of acquisition of informed consent was 17.13 out of 35, indicating that the quality falls in the inappropriate category. The results indicate that 48% of the signatories do not even read the form before signing it. Among the 52% who did read the consent form, 61.3% mentioned varying degrees of incomprehensibility of the consent form and 94.2% mentioned the presence of incomprehensible technical, medical and legal vocabulary. Only 12% and 18% of respondents reported that they were not in hurry and they had no fear or anxiety, respectively, when signing the form. The quality of obtaining informed consent was higher in women, younger patients, patients with higher education, and those who had special surgeries. Discussion: This study shows a poor practice in obtaining surgical informed consent in Iran. It seems necessary to consider fundamental changes in the process of acquiring consent based on the temporal and local conditions of the patients. Keywords Informed consent, Iran, surgery
Corresponding author: Somayeh Faghanipour, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON M5T 1P8, Canada. Email: [email protected]; [email protected]
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Introduction In traditional, paternalistic approach, patients have to rely entirely on the physicians and their decisions. Nowadays, the importance of autonomy of patients is being recognized increasingly, this approach is being progressively replaced by one which gets the patient involved in the decision making process. This is reflected in the acquisition of a valid informed consent.1 Obtaining informed consent entails the provision of necessary and sufficient information regarding the risks and benefits and alternative therapies, involving the patient in decisions. The informed consent form is a document indicating that the conversation between the surgeon and the patient has resulted in mutual understanding.2 Complying with the standards of acquiring informed consent directly affects the outcome of therapy and patients’ satisfaction; previous studies indicate a relationship between adequate informed consent and improved clinical outcomes including mental health, pain and symptom resolution, enhanced function and physiologic criteria, better compliance of the patient with medical therapy, and patient’s satisfaction.3–5 Moreover, it decreases the number of legal complaints against surgeons, hospitals, and other healthcare providers, reducing legal and judiciary interventions in general.6 The findings of a Dutch study indicated that 17% of surgeons had faced legal prosecution over the last 5 years regarding their informed consent for surgery.7 Paying attention to this issue will reduce the legal involvement of physicians and the Ministry of Health, the Medical Council, and other related organizations. The informed consent is valid only when it is obtained in an interactive manner, providing patients complete information regarding the suggested therapy and enable them to make an informed decision.7 In addition, the consent is valid only when obtained from a patient who is capable of making decision, who has received enough information, and who is not under pressure to sign the form.8 For this purpose, the physician and other healthcare staff need to provide an environment free of tension where the signatory receives the information without any stress or anxiety and obtain the informed consent only after making sure that the patient has comprehended the information provided. Beside, the consent forms must be designed in accordance with the patient’s conditions (age, understanding capacity, and type of surgery) and administered to the patient in a calm and reassuring environment after the necessary information is provided by the surgeon or the surgeon’s assistant.8 Despite the importance of consent in healthcare ethics and the consensus of previous studies on the indispensability of a valid informed consent, it is often observed that the heavy workload in university hospitals in Iran reduces the acquisition of an informed consent to a mere signature on a form, and the term ‘informed consent’ brings to mind a long form delivered to the patient or his companion on admission or at the doors of the operating room, conditioning the surgery to signing this form.5 This has led to a wide gap between the theoretical and legal aspects of informed consent and what is actually taking place in hospitals.6 During my nursing practice in Iran, I (the corresponding author) figured out that, in some cases, consent is obtained from a person who is not legally allowed to give a consent on behalf of the patient, and in many cases, staff other than healthcare staff, such as admission clerks, acquire the consent without providing any information. Very few studies have been conducted on this issue in Iran. Sheikhtaheri and Farzandipour1 conducted a study on 300 patients undergoing surgery in three teaching hospitals in Kashan and reported the status of informed consents to be inappropriate. In a small study on 80 patients admitted to three hospitals in Tehran, 46.7% of patients had not read the informed consent form at all and only 28.4% of the patients had read and understood the form completely.9 Akkad et al.’s10 study regarding the patients’ attitude toward surgical consent forms showed that 46% of patients believed that the most important function of the consent form is to save the hospital from legal prosecutions, and two-thirds of them believed that informed consent grants control to the physician. A Nigerian study by Ogundiran and Adebamowo11 reported that 54.9% of physicians believed that sufficient information is not given to patients during acquisition of an informed consent,
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and about half the physicians believed the consent form to be more of a legal formality prior to surgery rather than a means to have the patient involved in the treatment process. On the other hand, in some other countries, informed consent practice seems to be better. A study in Auckland indicated that 86% of patients had sufficient time to read the consent form before signing it and only 38% of patients had experienced degrees of tensions and pressure when signing the form.12 Another study by Kang et al.13 in Korea reported that 68.5% of patients had mentioned that they had been given enough time for giving an informed consent about their surgery. In general, previous studies indicate certain shortcomings in consent practice in some countries, including Iran. It seems that ethical and legal standards of obtaining an adequate informed consent are not fully considered in Iran. This study aims to evaluate the current practice of acquisition of surgical informed consent in hospitals affiliated with Tehran University of Medical Sciences (TUMS). Since Tehran is considered the medical center of country and in addition to its inhabitants, many patients are referred to Tehran for surgeries,14 this study was conducted in this city.
Method This is a cross-sectional, descriptive-analytical study to assess the acquisition of informed consent for surgery. Study samples consisted of 300 patients undergoing surgery in select hospitals affiliated with TUMS, selected through multistage, stratified sampling with proportionate allocation. The study environment consisted of seven hospitals affiliated with TUMS, selected from 24 teaching hospitals after elimination of psychiatric and pediatric hospitals, using a table of randomized numbers. Subsequently, the number of patients selected from each hospital was determined based on the number of active beds. Patients fulfilling the inclusion criteria and willing to participate were recruited on morning and evening shifts from different surgical wards. The inclusion criteria were age over 18 years, lack of mental disorders or any other condition affecting the patient’s reasoning and judgment, and the patient’s willingness to participate in the study. Patients were asked whether the informed consent form had signed by them or by a surrogate. If a surrogate was involved in the informed consent process, the questionnaire was completed by the signatory. The study was approved by research ethics committee at TUMS. All participants provided their written informed consent for participating in the study. The patients were reassured about the anonymity of their information and the fact that their answers will not affect their treatment and care. Data were collected using a questionnaire completed by interview 1–3 days after surgery. The questionnaire consisted of a general and a specific section. The general section inquired about the personal characteristics of the patient (age, sex, frequency of admission, education level, residence, and type of surgery). The specific sections had 14 questions, 7 questions were designed using a Likert scale. The other seven questions were multiple choice with a different structure. The later group of questions inquired about the person signing the consent form, the person signing the consent form as witness, the person obtaining the consent, the person providing the information about surgery, the time when information was provided, consciousness level of the patient when giving consent, and allocating a place for sitting to give the consent. The signatory’s condition when signing the consent form and the form’s comprehensibility were assessed with seven questions based on Likert scale (from 0 to 5 points). The overall score ranged from 0 to 35. Higher scores represented better conditions of acquisition of consent form. In general, mean scores below 50% (scores below 17.5 points) were deemed inappropriate, 50%–75% (17.5–26.25 points) were deemed average, and over 75% (more than 26.25 points) were deemed appropriate. The questionnaire was developed after consulting the relevant literature. We determined the validity of our questionnaire by asking four experts in medical ethics and six faculty members to review and comment on the questionnaire; a primordial version of a self-designed questionnaire and a paper
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contained general and specific objectives of our study were given to them and they were asked to suggest on the questionnaire according to our study objectives and point the ambiguities and linguistic errors; their suggestions were used to revise the questionnaire. Improved version was tested on 12 randomly selected patients; based on the responses, remaining ambiguities were eliminated. The internal reliability of the questionnaire was evaluated with Cronbach’s alpha in the following manner: the questionnaire was given to 20 persons who fulfilled the inclusion criteria to complete the questionnaire. Afterwards, the internal reliability of the questionnaire was approved with 0.85. Data were analyzed on SPSS software version 16 using descriptive and analytical statistics, including frequency, mean, standard deviations, and Spearman’s and Pearson’s correlation coefficient.
Results The mean age of participants was 43.55 + 14.7 years. Women accounted for 51.3% of the participants, and the mean frequency of admission was 2.5 times. The overall level of education was low; 71.3% of respondents were educated below high school diploma. Most patients (68%) were not inhabitants of Tehran and had referred to Tehran from other townships for surgery. The adequacy of obtained informed consent was associated with age, sex, the level of education, and the type of surgery. The quality of obtained informed consent was higher in women, younger patients, patients with higher education, and those who had special surgeries (Table 1). The form was signed by the patient in 70% of cases, by a partner or parents in 11% of cases, and by other people (an individual rather than the legal guardian) in 19% of cases. The result of independent sample t-test showed no significant difference in the adequacy of obtained consent between surrogate versus nonsurrogate consent. However, in two scopes, the surrogate consents were more adequate: surrogate signatories read the forms more than patients themselves and had less fear and anxiety while reading the form (Table 2). The forms were signed without a witness in 53.3% of cases. It was witnessed in 21% of cases by partner or parents, in 4.7% of cases by the patient, in 2.7% of cases by a nurse, and in 18.3% of cases by other individuals. In 87% of cases, the consent form was provided by admission clerks, in 16.3% by a nurse, and only in 2.3% of cases it was provided by a physician. In all, 3.3% of participants expressed that they did not know the position and role of the person who provided the form. In 85% of cases, information about the surgery was provided by the surgeon, in 9.3% by a nurse, and in very few cases by other healthcare staff. In 76.3% of cases, the information was provided before admission and during the visits. Only in 4.7% of cases, the information was provided during acquisition of informed consent. In 89.7% of cases, the patients were fully conscious before surgery. In 61.3% of cases, the consent form had been signed while the signatory was standing up and no seat had been offered to them while reading the consent form. In general, the mean score of quality of acquisition of informed consent before surgery was 17.13 out of 35 points, placing it in the inappropriate category (Table 3).
Discussion The findings of this study indicate an inappropriate practice in obtaining consent form for surgery in studied hospitals. Although obtaining informed consent for surgical procedures is a legal requirement in Iran, but it seems it is most often done as a momentary pre-operative routine rather than a truly participatory decision making process.
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Table 1. Basic information of participants and the relationship with amount of information received. Variable Age (years) 18–40 41–62 63–82 Sex Male Female Education Illiterate Elementary school High school diploma College Bachelor’s Master’s or higher Residence Tehran Other townships Type of surgery General surgery Specialized surgery
Count (%)
Association between quality of acquisition of informed consent score and basic information (p value)
140 (46.7) 123 (41) 37 (12.3)
0.007
146 (48.7) 154 (51.3)
0.00
64 (21.3) 150 (50) 53 (17.7) 13 (4.3) 18 (6) 2 (0.7)
0.05
96 (32) 204 (68)
0.78
148 (49.3) 152 (50.7)
0.005
Table 2. Comparing the quality of informed consent in surrogate versus non-surrogate consents. Mean + SD Question 1 2 3 4 5 6 7
Patients
Surrogates
Reading the consent form 1.4 + 1.73 1.88 + 1.68 Explanations on the form by the person providing the form 1.4 + 1.45 1.38 + 1.43 Being in a hurry when signing the form 2.85 + 1.86 2.57 + 1.72 Having fear and anxiety when signing the form 3.05 + 1.86 2.48 + 1.84 Having enough time to think and ask questions when signing the form 2.78 + 1.41 2.79 + 1.26 Comprehending the form after reading it 2.86 + 1.84 3.12 + 1.04 Presence of incomprehensible technical, medical and legal words in the form 2.81 + 1.25 2.6 + 1.21 Total 17.15 16.86
p value 0.02 0.92 0.22 0.01 0.17 0.30 0.96 0.64
SD: standard deviation.
Factors affecting the quality of informed consent Our study shows the quality of obtained informed consent is associated with the level of education, sex, age, and the type of surgery (Table 1). Higher educated signatories had a more adequate informed consent. Our finding is in line with a study in Iran1 that showed a direct relationship between the level of education and the perceived quality of informed consent process. A possible explanation of this result is that illiterate and lower literate patients are more likely to be ignored in the process of obtaining the informed consent. This result highlights the importance of considering the patient’s level of education during the consent process. In our study, younger patients had a more adequate informed consent process, a likely explanation is
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Table 3. Quality of acquisition of informed consent in teaching hospitals affiliated with Tehran University of Medical Sciences. Response n (%) Question
Not at all
Very little
1 Reading the consent 144 (48) 27 (9) form 2 Explanations on the 124 (41.3) 52 (17.3) form by the person providing the form 36 (12) 70 (23.3) 3 Being in a hurry when signing the form 55 (18.4) 25 (8.3) 4 Having fear and anxiety when signing the form 38 (12.7) 23 (7.7) 5 Having enough time to think and ask questions when signing the form 8 (5.1) 8 (5.1) 6 Comprehending the form after reading it 9 (5.8) 27 (17.3) 7 Presence of incomprehensible technical, medical and legal words in the form Total
Total
Mean + SD
38 (12.7) 17 (5.7)
300 (100)
1.54 + 1.73
40 (13.4) 54 (18)
27 (9)
3 (1)
300 (100)
1.39 + 1.44
30 (10)
33 (11)
87 (29)
300 (100)
2.76 + 1.82
25 (8.3)
98 (32.7) 300 (100)
2.88 + 1.87
Little 23 (7.7)
Medium 51 (17)
44 (14.7)
43 (14.3) 54 (18)
30 (10)
Much
97 (23.3) 105 (35)
Very much
7 (2.3)
300 (100)
2.87 + 1.36
24 (15.4) 65 (41.7)
44 (28.2)
7 (4.5)
156 (100)
2.96 + 1.13
70 (44.8) 26 (16.7)
11 (7.1)
13 (8.3)
156 (100)
2.73 + 1.24
17.13
SD: standard deviation.
normally younger patients are more educated and in our study we find a direct correlation between age and education as well (p < 0.00). Patients who had a special surgery reported a more adequate informed consent process. Another study also reported that those undergoing special surgeries usually received more information than patients who are undergoing general surgeries.1 This can be interpreted that with the increased risk of surgery, healthcare professionals act more responsible in obtaining an adequate informed consent. One possible positive explanation of this finding is that healthcare professionals really believe patients need more support during the informed consent process for a more sensitive surgery; another, more skeptical explanation could be that the informed consent in special surgeries are being done in more adequate way to reduce the potential liability of hospitals and healthcare practitioners. Future studies are needed to better understand the factors affecting the clinician’s practice in obtaining surgical informed consent in Iran.
Who obtained the informed consent? In 87% of cases, the consent form was provided by admission clerks, and only in 2.3% of cases, the form was provided by a physician. Since most admission staff do not have medical background and cannot answer the
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patient’s medical questions, acquisition of informed consent by them will disrupt the chain of shared decision making and patient’s involvement in treatment and is considered as an invalid consent. This finding is in line with a report from Nigeria where the consent form was acquired by the surgeon in only 4% of cases, and the majority of consent forms were obtained by other members of the surgery team. In that study in 16% of cases, the patients did not even know the person who obtained their consent, saying that the person had just obtained consent without even introducing themselves.15 Current guidelines on informed consent state that the consent should be obtained by the person who is able to perform the procedure himself and has been trained for explaining it to patients.8,16
Timing and condition of obtaining informed consent In 76.3% of cases, the information related to surgery was provided before admission and on visit. In 87% of cases, the informed consent was obtained during admission. On the other hand, it has been recommended to obtain informed consent at the time of listening in clinic, when the benefits and risks of surgery are often explained to the patient, as this puts less pressure on the patient. In addition, as the patient may develop doubts on the day he or she is supposed to undergo surgery, and they may feel obliged to accept it because of the preparations made, it is better to reaffirm the consent on the day of surgery, if the consent is previously obtained.8 Since the purpose of acquiring an informed consent is to involve the patient as an active agent in the process of making decisions, the patient must be given enough time to contemplate and should not be put under any pressure or urgency. Such pressure may be felt by the patient because the provider of the form is waiting for their signature, and the feeling that the routine activities of a busy hospital are interrupted by their delay may make patients avoid asking questions, rendering the acquisition of informed consent into a formalistic procedure.17 The importance of giving sufficient time to the patient is reflected in the findings of a study in which the assignment of sufficient time to the patient was the most important predicting factor for comprehension of information by the patient.18 As both the patient and his or her companions are in a hurry on admission, it seems that it would not be appropriate, time wise and location wise, to obtain the informed consent then and there, as only 12% and 18% of participants reported that they were not in hurry and they had no fear or anxiety, respectively, when signing the form and only 37.2% of respondents stated that they had enough time to think and ask questions when completing the form. On the other hand, a study in Auckland reported that 86% of patients had sufficient time to read the consent form prior to signing it, and only 38% had experienced some degree of tension or pressure when signing the form.12 Another study from England reported that sufficient time has been given to 91% of patients for completing the informed consent form.19 Osime et al.15 reported that 66.5% of Nigerian patients expressed they had enough time for contemplating the consent form. One possible reason for the fact that 48% of participants in our study had not read the consent form at all may be the inappropriate time and place of acquiring the informed consent. Moreover, 61.3% of participants in our study had signed the form while standing up without having a place to sit while reading the form. This situation causes discomfort for the signatory, resulting in hurried and careless reading of the form.
Who signed the form and the effect of culture In this study, 89.7% of patients had the decision making capacity to provide consent in person (age above 18 years, lack of psychiatric disorders or any condition that affects reasoning and judgment, and being fully conscious when the consent was obtained). Despite this, consent was obtained from patients themselves in 70% of cases, shows that in 19.7% of cases, consent were acquired from another person in spite of the fact that those patients were able to provide it themselves. Those consents show the clinicians are not familiar with consent law. A family member consenting for a patient who has decision making capacity is not an
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unusual practice in Iran. Although this practice is legally and ethically wrong, it is happening as a result of cultural norms and lack of supervisory measurements on informed consent practice. In Western culture, decision making is based on individual’s right and autonomy. However, patients in Iran are likely to define themselves as relative to, rather than independent of, the rest of their family. Major decisions usually involve all members of the family, and the concept of autonomy is being shared by the family members. This cultural norm should not override the patient’s own right to make decisions for their treatments and care. Healthcare professionals should always consider the patient as the first informed and consulted with person, while respecting the cultural tradition of family caring. The majorities of Iranians are Muslim, for a Muslim patient normally health, illness, and death depend on ‘‘God’s will’’ for their life. The physician might be considered as an instrument of God rather than a well-trained expert who provide service to a customer. This belief might justify why some patients leave themselves in the hand of their surgeons without questioning. This is happening while surgeons are being trained in a secular scientific way. This fatalistic belief among patients and unquestioned authority of healthcare professionals can leave the patients vulnerable to exploitation.20 Besides, while providing culturally informed care is important, clinicians should never forget the dynamic and ever-changing nature of cultures and keep in mind that each patient is a unique individual with his or own personal beliefs and practices.21
Understandability of the informed consent forms Among those 52% who had read the consent form, 61.3% expressed not having understood the form to various degrees, and 94.2% mentioned that incomprehensible technical medical and legal words were present to varying degrees in the text. In a study conducted by Bottrell et al.21 on consent forms in American hospitals indicated that many consent forms are not textually appropriate for obtaining an informed consent and providing a basis for physician–patient interaction. In general, previous studies on patient rights in Iran indicate that although physicians and other healthcare staff are aware of the importance of observing patient rights, this awareness alone cannot guarantee the fulfillment of these rights by physicians or other healthcare personnel.22 A study by Joolaee et al.23 on patient rights in Iran indicated that three major factors, patients’ unawareness of their rights, shortage of resources (deficiencies in human resources, time and facilities, and particularly in teaching hospitals), and irresponsiveness of the surveillance system, account for the majority of cases in which patient rights are ignored. Based on this, it would be helpful to raise the awareness among the public of their rights as patients and reforming the structure of the surveillance system.24 This study attempted to provide a picture of the quality of obtaining informed consent from the patients’ point of view. As very few studies have been conducted on surgical informed consent in Iran, it appears necessary to address the issue from surgeons’ and healthcare practitioner’s point of view, as well. Moreover, since this study was conducted only on patients who were undergoing surgery in teaching hospitals, further studies are required to compare between public and private surgical facilities, as well.
Conclusion Considering our findings, we suggest fundamental reforms in the process of acquisition of informed consent for surgeries in Iran to guarantee patient’s involvement in their treatment and shared decision making and validate the process of acquiring the informed consent. Accomplishing this objective requires standardization of the process and making fundamental changes in hospital policies and surgical facilities in the manner of acquiring informed consent based on the temporal and spatial circumstances of the person acquiring the consent. Moreover, we recommend better supervision on the quality of acquisition of informed consent for surgeries in Iranian hospitals and surgical centers.
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We recommend that people should become aware of their rights to participate in their treatment plan via different media. Also, factors hindering the acquisition of valid consents must be identified and eliminated. The incorporation of the regulations pertaining to informed consent and the importance of active patient participation in treatment into the curricula of surgical residents and nurses, as well as into the continuing educational programs for physicians and operating room staff is recommended. Further studies should be done in order to address the factors preventing the acquisition of a valid informed consent for surgery and investigate the optimal solutions to them. Acknowledgements We thank the patients who kindly participated in this study. Conflict of interest The authors declare that there is no conflict of interests Funding This study was supported by Research Deputy of Tehran University of Medical Sciences (grant number 16130). References 1. Sheikhtaheri A and Farzandipour M. Factors associated with quality of informed consent in patients admitted for surgery: an Iranian study. AJOB Prim Res 2010; 1(4): 9–16. 2. Jukic M, Kvolik S, Kardum G, et al. Knowledge and practices of obtaining informed consent for medical procedures among specialist physicians: questionnaire study in 6 Croatian hospitals. Croat Med J 2009; 50(6): 567–574. 3. Walker JA. What is the effect of preoperative information on patient satisfaction? Br J Nurs 2007; 16(1): 27–32. 4. Greenfield S, Kaplan S and Ware JE. Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med 1985; 102(4): 520–528. 5. Parsapour A, Parsapour MB and Larijani B. Informed consent, contents, conditions and practical methods. J Diabetes Metab Disord 2005; 5: 1–14 (in Persian). 6. Leclercq WK, Keulers BJ, Scheltinga MR, et al. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg 2010; 34(7): 1406–1415. 7. Leclercq WK, Keulers BJ, Houterman S, et al. A survey of the current practice of the informed consent process in general surgery in the Netherlands. Patient Saf Surg 2013; 7(1): 4. 8. Anderson OA and Wearne IM. Informed consent for elective surgery—what is best practice? J R Soc Med 2007; 100(2): 97–100. 9. Amini M, Mousavi S and Mohammadnejad S. Assessment of the quality of informed consent obtained from patients in selected hospitals of Tehran University of Medical Sciences. J Med Ethics Hist Med 2009; 2(3): 61–65 (in Persian). 10. Akkad A, Jackson C, Kenyon S, et al. Patients’ perceptions of written consent: questionnaire study. BMJ 2006; 333(7567): 528. 11. Ogundiran TO and Adebamowo CA. Surgeons’ opinions and practice of informed consent in Nigeria. J Med Ethics 2010; 36(12): 741–745. 12. McKeague M and Windsor J. Patients’ perception of the adequacy of informed consent: a pilot study of elective general surgical patients in Auckland. N Z Med J 2003; 116(1170): U355. 13. Kang KD, Abdul Majid AS, Kwag JH, et al. A prospective audit on the validity of written informed consent prior to glaucoma surgery: an Asian perspective. Graefes Arch Clin Exp Ophthalmol 2010; 248(5): 687–701. 14. Aramesh K. An Iranian study or a Kashanian one? AJOB Prim Res 2010; 1(4): 17–18.
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15. Osime OC, Okojie O, Osadolor F, et al. Current practices and medico-legal aspects of pre-operative consent. East Afr Med J 2004; 81(7): 331–335. 16. UK Department of Health. Good practice in consent implementation guide: consent to examination or treatment. London: Department of Health, 2001, https://www.gov.uk/government/organisations/department-of-health 17. Schenker Y and Meisel A. Informed consent in clinical care: practical considerations in the effort to achieve ethical goals. JAMA 2011; 305(11): 1130–1131. 18. Fink AS, Prochazka AV, Henderson WG, et al. Predictors of comprehension during surgical informed consent. J Am Coll Surg 2010; 210(6): 919–926. 19. Howlader MH, Dhanji AR, Uppal R, et al. Patients’ views of the consent process for adult cardiac surgery: questionnaire survey. Scand Cardiovasc J 2004; 38(6): 363–368. 20. Moazam F. Families, patients, and physicians in medical decision making: a Pakistani perspective. Hastings Cent Rep 2000; 30(6): 28–37. 21. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Arch Surg 2000; 135(1): 26–33. 22. Joolaee S and Hajibabaee F. Patient rights in Iran: a review article. Nurs Ethics 2012; 19(1): 45–57. 23. Joolaee S, Tschudin V, Nikbakht-Nasrabadi A, et al. Factors affecting patients’ rights practice: the lived experiences of Iranian nurses and physicians. Int Nurs Rev 2008; 55(1): 55–61. 24. Joolaee S, Nikbakht-Nasrabadi A, Parsa-Yekta Z, et al. An Iranian perspective on patients’ rights. Nurs Ethics 2006; 13(5): 488–502.
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The quality of obtaining surgical informed consent: Case study in Iran
Nursing Ethics 1–10 ª The Author(s) 2015 Reprints and permission: sagepub.co.uk/journalsPermissions.nav 10.1177/0969733015584398 nej.sagepub.com
Soodabeh Joolaee Iran University of Medical Sciences, Iran; University of British Colombia, Canada
Somayeh Faghanipour University of Toronto, Canada
Fatemeh Hajibabaee Tehran University of Medical Sciences, Iran
Abstract Background: Informed consent goes beyond signing a form; it is a process of providing necessary information, helping patients make an informed decision, and actively participate in their treatment. Aim/objective: This study aimed to assess the quality of obtaining surgical informed consent in hospitals affiliated with Tehran University of Medical Sciences. Research design/participants/context: In a cross-sectional, descriptive-analytical study, 300 patients were chosen through stratified sampling from seven hospitals affiliated with Tehran University of Medical Sciences. Data were collected using a questionnaire developed by the researchers and analyzed using descriptive and analytical statistics on SPSS software. Ethical considerations: Ethical approval of this study was granted by Tehran University of Medical Sciences research ethics committee. Written informed consent for participation was obtained. The participants were reassured that their information will be used anonymously and their answers will not affect their treatment and care. Findings: The mean score of quality of acquisition of informed consent was 17.13 out of 35, indicating that the quality falls in the inappropriate category. The results indicate that 48% of the signatories do not even read the form before signing it. Among the 52% who did read the consent form, 61.3% mentioned varying degrees of incomprehensibility of the consent form and 94.2% mentioned the presence of incomprehensible technical, medical and legal vocabulary. Only 12% and 18% of respondents reported that they were not in hurry and they had no fear or anxiety, respectively, when signing the form. The quality of obtaining informed consent was higher in women, younger patients, patients with higher education, and those who had special surgeries. Discussion: This study shows a poor practice in obtaining surgical informed consent in Iran. It seems necessary to consider fundamental changes in the process of acquiring consent based on the temporal and local conditions of the patients. Keywords Informed consent, Iran, surgery
Corresponding author: Somayeh Faghanipour, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON M5T 1P8, Canada. Email: [email protected]; [email protected]
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Introduction In traditional, paternalistic approach, patients have to rely entirely on the physicians and their decisions. Nowadays, the importance of autonomy of patients is being recognized increasingly, this approach is being progressively replaced by one which gets the patient involved in the decision making process. This is reflected in the acquisition of a valid informed consent.1 Obtaining informed consent entails the provision of necessary and sufficient information regarding the risks and benefits and alternative therapies, involving the patient in decisions. The informed consent form is a document indicating that the conversation between the surgeon and the patient has resulted in mutual understanding.2 Complying with the standards of acquiring informed consent directly affects the outcome of therapy and patients’ satisfaction; previous studies indicate a relationship between adequate informed consent and improved clinical outcomes including mental health, pain and symptom resolution, enhanced function and physiologic criteria, better compliance of the patient with medical therapy, and patient’s satisfaction.3–5 Moreover, it decreases the number of legal complaints against surgeons, hospitals, and other healthcare providers, reducing legal and judiciary interventions in general.6 The findings of a Dutch study indicated that 17% of surgeons had faced legal prosecution over the last 5 years regarding their informed consent for surgery.7 Paying attention to this issue will reduce the legal involvement of physicians and the Ministry of Health, the Medical Council, and other related organizations. The informed consent is valid only when it is obtained in an interactive manner, providing patients complete information regarding the suggested therapy and enable them to make an informed decision.7 In addition, the consent is valid only when obtained from a patient who is capable of making decision, who has received enough information, and who is not under pressure to sign the form.8 For this purpose, the physician and other healthcare staff need to provide an environment free of tension where the signatory receives the information without any stress or anxiety and obtain the informed consent only after making sure that the patient has comprehended the information provided. Beside, the consent forms must be designed in accordance with the patient’s conditions (age, understanding capacity, and type of surgery) and administered to the patient in a calm and reassuring environment after the necessary information is provided by the surgeon or the surgeon’s assistant.8 Despite the importance of consent in healthcare ethics and the consensus of previous studies on the indispensability of a valid informed consent, it is often observed that the heavy workload in university hospitals in Iran reduces the acquisition of an informed consent to a mere signature on a form, and the term ‘informed consent’ brings to mind a long form delivered to the patient or his companion on admission or at the doors of the operating room, conditioning the surgery to signing this form.5 This has led to a wide gap between the theoretical and legal aspects of informed consent and what is actually taking place in hospitals.6 During my nursing practice in Iran, I (the corresponding author) figured out that, in some cases, consent is obtained from a person who is not legally allowed to give a consent on behalf of the patient, and in many cases, staff other than healthcare staff, such as admission clerks, acquire the consent without providing any information. Very few studies have been conducted on this issue in Iran. Sheikhtaheri and Farzandipour1 conducted a study on 300 patients undergoing surgery in three teaching hospitals in Kashan and reported the status of informed consents to be inappropriate. In a small study on 80 patients admitted to three hospitals in Tehran, 46.7% of patients had not read the informed consent form at all and only 28.4% of the patients had read and understood the form completely.9 Akkad et al.’s10 study regarding the patients’ attitude toward surgical consent forms showed that 46% of patients believed that the most important function of the consent form is to save the hospital from legal prosecutions, and two-thirds of them believed that informed consent grants control to the physician. A Nigerian study by Ogundiran and Adebamowo11 reported that 54.9% of physicians believed that sufficient information is not given to patients during acquisition of an informed consent,
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and about half the physicians believed the consent form to be more of a legal formality prior to surgery rather than a means to have the patient involved in the treatment process. On the other hand, in some other countries, informed consent practice seems to be better. A study in Auckland indicated that 86% of patients had sufficient time to read the consent form before signing it and only 38% of patients had experienced degrees of tensions and pressure when signing the form.12 Another study by Kang et al.13 in Korea reported that 68.5% of patients had mentioned that they had been given enough time for giving an informed consent about their surgery. In general, previous studies indicate certain shortcomings in consent practice in some countries, including Iran. It seems that ethical and legal standards of obtaining an adequate informed consent are not fully considered in Iran. This study aims to evaluate the current practice of acquisition of surgical informed consent in hospitals affiliated with Tehran University of Medical Sciences (TUMS). Since Tehran is considered the medical center of country and in addition to its inhabitants, many patients are referred to Tehran for surgeries,14 this study was conducted in this city.
Method This is a cross-sectional, descriptive-analytical study to assess the acquisition of informed consent for surgery. Study samples consisted of 300 patients undergoing surgery in select hospitals affiliated with TUMS, selected through multistage, stratified sampling with proportionate allocation. The study environment consisted of seven hospitals affiliated with TUMS, selected from 24 teaching hospitals after elimination of psychiatric and pediatric hospitals, using a table of randomized numbers. Subsequently, the number of patients selected from each hospital was determined based on the number of active beds. Patients fulfilling the inclusion criteria and willing to participate were recruited on morning and evening shifts from different surgical wards. The inclusion criteria were age over 18 years, lack of mental disorders or any other condition affecting the patient’s reasoning and judgment, and the patient’s willingness to participate in the study. Patients were asked whether the informed consent form had signed by them or by a surrogate. If a surrogate was involved in the informed consent process, the questionnaire was completed by the signatory. The study was approved by research ethics committee at TUMS. All participants provided their written informed consent for participating in the study. The patients were reassured about the anonymity of their information and the fact that their answers will not affect their treatment and care. Data were collected using a questionnaire completed by interview 1–3 days after surgery. The questionnaire consisted of a general and a specific section. The general section inquired about the personal characteristics of the patient (age, sex, frequency of admission, education level, residence, and type of surgery). The specific sections had 14 questions, 7 questions were designed using a Likert scale. The other seven questions were multiple choice with a different structure. The later group of questions inquired about the person signing the consent form, the person signing the consent form as witness, the person obtaining the consent, the person providing the information about surgery, the time when information was provided, consciousness level of the patient when giving consent, and allocating a place for sitting to give the consent. The signatory’s condition when signing the consent form and the form’s comprehensibility were assessed with seven questions based on Likert scale (from 0 to 5 points). The overall score ranged from 0 to 35. Higher scores represented better conditions of acquisition of consent form. In general, mean scores below 50% (scores below 17.5 points) were deemed inappropriate, 50%–75% (17.5–26.25 points) were deemed average, and over 75% (more than 26.25 points) were deemed appropriate. The questionnaire was developed after consulting the relevant literature. We determined the validity of our questionnaire by asking four experts in medical ethics and six faculty members to review and comment on the questionnaire; a primordial version of a self-designed questionnaire and a paper
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contained general and specific objectives of our study were given to them and they were asked to suggest on the questionnaire according to our study objectives and point the ambiguities and linguistic errors; their suggestions were used to revise the questionnaire. Improved version was tested on 12 randomly selected patients; based on the responses, remaining ambiguities were eliminated. The internal reliability of the questionnaire was evaluated with Cronbach’s alpha in the following manner: the questionnaire was given to 20 persons who fulfilled the inclusion criteria to complete the questionnaire. Afterwards, the internal reliability of the questionnaire was approved with 0.85. Data were analyzed on SPSS software version 16 using descriptive and analytical statistics, including frequency, mean, standard deviations, and Spearman’s and Pearson’s correlation coefficient.
Results The mean age of participants was 43.55 + 14.7 years. Women accounted for 51.3% of the participants, and the mean frequency of admission was 2.5 times. The overall level of education was low; 71.3% of respondents were educated below high school diploma. Most patients (68%) were not inhabitants of Tehran and had referred to Tehran from other townships for surgery. The adequacy of obtained informed consent was associated with age, sex, the level of education, and the type of surgery. The quality of obtained informed consent was higher in women, younger patients, patients with higher education, and those who had special surgeries (Table 1). The form was signed by the patient in 70% of cases, by a partner or parents in 11% of cases, and by other people (an individual rather than the legal guardian) in 19% of cases. The result of independent sample t-test showed no significant difference in the adequacy of obtained consent between surrogate versus nonsurrogate consent. However, in two scopes, the surrogate consents were more adequate: surrogate signatories read the forms more than patients themselves and had less fear and anxiety while reading the form (Table 2). The forms were signed without a witness in 53.3% of cases. It was witnessed in 21% of cases by partner or parents, in 4.7% of cases by the patient, in 2.7% of cases by a nurse, and in 18.3% of cases by other individuals. In 87% of cases, the consent form was provided by admission clerks, in 16.3% by a nurse, and only in 2.3% of cases it was provided by a physician. In all, 3.3% of participants expressed that they did not know the position and role of the person who provided the form. In 85% of cases, information about the surgery was provided by the surgeon, in 9.3% by a nurse, and in very few cases by other healthcare staff. In 76.3% of cases, the information was provided before admission and during the visits. Only in 4.7% of cases, the information was provided during acquisition of informed consent. In 89.7% of cases, the patients were fully conscious before surgery. In 61.3% of cases, the consent form had been signed while the signatory was standing up and no seat had been offered to them while reading the consent form. In general, the mean score of quality of acquisition of informed consent before surgery was 17.13 out of 35 points, placing it in the inappropriate category (Table 3).
Discussion The findings of this study indicate an inappropriate practice in obtaining consent form for surgery in studied hospitals. Although obtaining informed consent for surgical procedures is a legal requirement in Iran, but it seems it is most often done as a momentary pre-operative routine rather than a truly participatory decision making process.
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Table 1. Basic information of participants and the relationship with amount of information received. Variable Age (years) 18–40 41–62 63–82 Sex Male Female Education Illiterate Elementary school High school diploma College Bachelor’s Master’s or higher Residence Tehran Other townships Type of surgery General surgery Specialized surgery
Count (%)
Association between quality of acquisition of informed consent score and basic information (p value)
140 (46.7) 123 (41) 37 (12.3)
0.007
146 (48.7) 154 (51.3)
0.00
64 (21.3) 150 (50) 53 (17.7) 13 (4.3) 18 (6) 2 (0.7)
0.05
96 (32) 204 (68)
0.78
148 (49.3) 152 (50.7)
0.005
Table 2. Comparing the quality of informed consent in surrogate versus non-surrogate consents. Mean + SD Question 1 2 3 4 5 6 7
Patients
Surrogates
Reading the consent form 1.4 + 1.73 1.88 + 1.68 Explanations on the form by the person providing the form 1.4 + 1.45 1.38 + 1.43 Being in a hurry when signing the form 2.85 + 1.86 2.57 + 1.72 Having fear and anxiety when signing the form 3.05 + 1.86 2.48 + 1.84 Having enough time to think and ask questions when signing the form 2.78 + 1.41 2.79 + 1.26 Comprehending the form after reading it 2.86 + 1.84 3.12 + 1.04 Presence of incomprehensible technical, medical and legal words in the form 2.81 + 1.25 2.6 + 1.21 Total 17.15 16.86
p value 0.02 0.92 0.22 0.01 0.17 0.30 0.96 0.64
SD: standard deviation.
Factors affecting the quality of informed consent Our study shows the quality of obtained informed consent is associated with the level of education, sex, age, and the type of surgery (Table 1). Higher educated signatories had a more adequate informed consent. Our finding is in line with a study in Iran1 that showed a direct relationship between the level of education and the perceived quality of informed consent process. A possible explanation of this result is that illiterate and lower literate patients are more likely to be ignored in the process of obtaining the informed consent. This result highlights the importance of considering the patient’s level of education during the consent process. In our study, younger patients had a more adequate informed consent process, a likely explanation is
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Table 3. Quality of acquisition of informed consent in teaching hospitals affiliated with Tehran University of Medical Sciences. Response n (%) Question
Not at all
Very little
1 Reading the consent 144 (48) 27 (9) form 2 Explanations on the 124 (41.3) 52 (17.3) form by the person providing the form 36 (12) 70 (23.3) 3 Being in a hurry when signing the form 55 (18.4) 25 (8.3) 4 Having fear and anxiety when signing the form 38 (12.7) 23 (7.7) 5 Having enough time to think and ask questions when signing the form 8 (5.1) 8 (5.1) 6 Comprehending the form after reading it 9 (5.8) 27 (17.3) 7 Presence of incomprehensible technical, medical and legal words in the form Total
Total
Mean + SD
38 (12.7) 17 (5.7)
300 (100)
1.54 + 1.73
40 (13.4) 54 (18)
27 (9)
3 (1)
300 (100)
1.39 + 1.44
30 (10)
33 (11)
87 (29)
300 (100)
2.76 + 1.82
25 (8.3)
98 (32.7) 300 (100)
2.88 + 1.87
Little 23 (7.7)
Medium 51 (17)
44 (14.7)
43 (14.3) 54 (18)
30 (10)
Much
97 (23.3) 105 (35)
Very much
7 (2.3)
300 (100)
2.87 + 1.36
24 (15.4) 65 (41.7)
44 (28.2)
7 (4.5)
156 (100)
2.96 + 1.13
70 (44.8) 26 (16.7)
11 (7.1)
13 (8.3)
156 (100)
2.73 + 1.24
17.13
SD: standard deviation.
normally younger patients are more educated and in our study we find a direct correlation between age and education as well (p < 0.00). Patients who had a special surgery reported a more adequate informed consent process. Another study also reported that those undergoing special surgeries usually received more information than patients who are undergoing general surgeries.1 This can be interpreted that with the increased risk of surgery, healthcare professionals act more responsible in obtaining an adequate informed consent. One possible positive explanation of this finding is that healthcare professionals really believe patients need more support during the informed consent process for a more sensitive surgery; another, more skeptical explanation could be that the informed consent in special surgeries are being done in more adequate way to reduce the potential liability of hospitals and healthcare practitioners. Future studies are needed to better understand the factors affecting the clinician’s practice in obtaining surgical informed consent in Iran.
Who obtained the informed consent? In 87% of cases, the consent form was provided by admission clerks, and only in 2.3% of cases, the form was provided by a physician. Since most admission staff do not have medical background and cannot answer the
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patient’s medical questions, acquisition of informed consent by them will disrupt the chain of shared decision making and patient’s involvement in treatment and is considered as an invalid consent. This finding is in line with a report from Nigeria where the consent form was acquired by the surgeon in only 4% of cases, and the majority of consent forms were obtained by other members of the surgery team. In that study in 16% of cases, the patients did not even know the person who obtained their consent, saying that the person had just obtained consent without even introducing themselves.15 Current guidelines on informed consent state that the consent should be obtained by the person who is able to perform the procedure himself and has been trained for explaining it to patients.8,16
Timing and condition of obtaining informed consent In 76.3% of cases, the information related to surgery was provided before admission and on visit. In 87% of cases, the informed consent was obtained during admission. On the other hand, it has been recommended to obtain informed consent at the time of listening in clinic, when the benefits and risks of surgery are often explained to the patient, as this puts less pressure on the patient. In addition, as the patient may develop doubts on the day he or she is supposed to undergo surgery, and they may feel obliged to accept it because of the preparations made, it is better to reaffirm the consent on the day of surgery, if the consent is previously obtained.8 Since the purpose of acquiring an informed consent is to involve the patient as an active agent in the process of making decisions, the patient must be given enough time to contemplate and should not be put under any pressure or urgency. Such pressure may be felt by the patient because the provider of the form is waiting for their signature, and the feeling that the routine activities of a busy hospital are interrupted by their delay may make patients avoid asking questions, rendering the acquisition of informed consent into a formalistic procedure.17 The importance of giving sufficient time to the patient is reflected in the findings of a study in which the assignment of sufficient time to the patient was the most important predicting factor for comprehension of information by the patient.18 As both the patient and his or her companions are in a hurry on admission, it seems that it would not be appropriate, time wise and location wise, to obtain the informed consent then and there, as only 12% and 18% of participants reported that they were not in hurry and they had no fear or anxiety, respectively, when signing the form and only 37.2% of respondents stated that they had enough time to think and ask questions when completing the form. On the other hand, a study in Auckland reported that 86% of patients had sufficient time to read the consent form prior to signing it, and only 38% had experienced some degree of tension or pressure when signing the form.12 Another study from England reported that sufficient time has been given to 91% of patients for completing the informed consent form.19 Osime et al.15 reported that 66.5% of Nigerian patients expressed they had enough time for contemplating the consent form. One possible reason for the fact that 48% of participants in our study had not read the consent form at all may be the inappropriate time and place of acquiring the informed consent. Moreover, 61.3% of participants in our study had signed the form while standing up without having a place to sit while reading the form. This situation causes discomfort for the signatory, resulting in hurried and careless reading of the form.
Who signed the form and the effect of culture In this study, 89.7% of patients had the decision making capacity to provide consent in person (age above 18 years, lack of psychiatric disorders or any condition that affects reasoning and judgment, and being fully conscious when the consent was obtained). Despite this, consent was obtained from patients themselves in 70% of cases, shows that in 19.7% of cases, consent were acquired from another person in spite of the fact that those patients were able to provide it themselves. Those consents show the clinicians are not familiar with consent law. A family member consenting for a patient who has decision making capacity is not an
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unusual practice in Iran. Although this practice is legally and ethically wrong, it is happening as a result of cultural norms and lack of supervisory measurements on informed consent practice. In Western culture, decision making is based on individual’s right and autonomy. However, patients in Iran are likely to define themselves as relative to, rather than independent of, the rest of their family. Major decisions usually involve all members of the family, and the concept of autonomy is being shared by the family members. This cultural norm should not override the patient’s own right to make decisions for their treatments and care. Healthcare professionals should always consider the patient as the first informed and consulted with person, while respecting the cultural tradition of family caring. The majorities of Iranians are Muslim, for a Muslim patient normally health, illness, and death depend on ‘‘God’s will’’ for their life. The physician might be considered as an instrument of God rather than a well-trained expert who provide service to a customer. This belief might justify why some patients leave themselves in the hand of their surgeons without questioning. This is happening while surgeons are being trained in a secular scientific way. This fatalistic belief among patients and unquestioned authority of healthcare professionals can leave the patients vulnerable to exploitation.20 Besides, while providing culturally informed care is important, clinicians should never forget the dynamic and ever-changing nature of cultures and keep in mind that each patient is a unique individual with his or own personal beliefs and practices.21
Understandability of the informed consent forms Among those 52% who had read the consent form, 61.3% expressed not having understood the form to various degrees, and 94.2% mentioned that incomprehensible technical medical and legal words were present to varying degrees in the text. In a study conducted by Bottrell et al.21 on consent forms in American hospitals indicated that many consent forms are not textually appropriate for obtaining an informed consent and providing a basis for physician–patient interaction. In general, previous studies on patient rights in Iran indicate that although physicians and other healthcare staff are aware of the importance of observing patient rights, this awareness alone cannot guarantee the fulfillment of these rights by physicians or other healthcare personnel.22 A study by Joolaee et al.23 on patient rights in Iran indicated that three major factors, patients’ unawareness of their rights, shortage of resources (deficiencies in human resources, time and facilities, and particularly in teaching hospitals), and irresponsiveness of the surveillance system, account for the majority of cases in which patient rights are ignored. Based on this, it would be helpful to raise the awareness among the public of their rights as patients and reforming the structure of the surveillance system.24 This study attempted to provide a picture of the quality of obtaining informed consent from the patients’ point of view. As very few studies have been conducted on surgical informed consent in Iran, it appears necessary to address the issue from surgeons’ and healthcare practitioner’s point of view, as well. Moreover, since this study was conducted only on patients who were undergoing surgery in teaching hospitals, further studies are required to compare between public and private surgical facilities, as well.
Conclusion Considering our findings, we suggest fundamental reforms in the process of acquisition of informed consent for surgeries in Iran to guarantee patient’s involvement in their treatment and shared decision making and validate the process of acquiring the informed consent. Accomplishing this objective requires standardization of the process and making fundamental changes in hospital policies and surgical facilities in the manner of acquiring informed consent based on the temporal and spatial circumstances of the person acquiring the consent. Moreover, we recommend better supervision on the quality of acquisition of informed consent for surgeries in Iranian hospitals and surgical centers.
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We recommend that people should become aware of their rights to participate in their treatment plan via different media. Also, factors hindering the acquisition of valid consents must be identified and eliminated. The incorporation of the regulations pertaining to informed consent and the importance of active patient participation in treatment into the curricula of surgical residents and nurses, as well as into the continuing educational programs for physicians and operating room staff is recommended. Further studies should be done in order to address the factors preventing the acquisition of a valid informed consent for surgery and investigate the optimal solutions to them. Acknowledgements We thank the patients who kindly participated in this study. Conflict of interest The authors declare that there is no conflict of interests Funding This study was supported by Research Deputy of Tehran University of Medical Sciences (grant number 16130). References 1. Sheikhtaheri A and Farzandipour M. Factors associated with quality of informed consent in patients admitted for surgery: an Iranian study. AJOB Prim Res 2010; 1(4): 9–16. 2. Jukic M, Kvolik S, Kardum G, et al. Knowledge and practices of obtaining informed consent for medical procedures among specialist physicians: questionnaire study in 6 Croatian hospitals. Croat Med J 2009; 50(6): 567–574. 3. Walker JA. What is the effect of preoperative information on patient satisfaction? Br J Nurs 2007; 16(1): 27–32. 4. Greenfield S, Kaplan S and Ware JE. Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med 1985; 102(4): 520–528. 5. Parsapour A, Parsapour MB and Larijani B. Informed consent, contents, conditions and practical methods. J Diabetes Metab Disord 2005; 5: 1–14 (in Persian). 6. Leclercq WK, Keulers BJ, Scheltinga MR, et al. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg 2010; 34(7): 1406–1415. 7. Leclercq WK, Keulers BJ, Houterman S, et al. A survey of the current practice of the informed consent process in general surgery in the Netherlands. Patient Saf Surg 2013; 7(1): 4. 8. Anderson OA and Wearne IM. Informed consent for elective surgery—what is best practice? J R Soc Med 2007; 100(2): 97–100. 9. Amini M, Mousavi S and Mohammadnejad S. Assessment of the quality of informed consent obtained from patients in selected hospitals of Tehran University of Medical Sciences. J Med Ethics Hist Med 2009; 2(3): 61–65 (in Persian). 10. Akkad A, Jackson C, Kenyon S, et al. Patients’ perceptions of written consent: questionnaire study. BMJ 2006; 333(7567): 528. 11. Ogundiran TO and Adebamowo CA. Surgeons’ opinions and practice of informed consent in Nigeria. J Med Ethics 2010; 36(12): 741–745. 12. McKeague M and Windsor J. Patients’ perception of the adequacy of informed consent: a pilot study of elective general surgical patients in Auckland. N Z Med J 2003; 116(1170): U355. 13. Kang KD, Abdul Majid AS, Kwag JH, et al. A prospective audit on the validity of written informed consent prior to glaucoma surgery: an Asian perspective. Graefes Arch Clin Exp Ophthalmol 2010; 248(5): 687–701. 14. Aramesh K. An Iranian study or a Kashanian one? AJOB Prim Res 2010; 1(4): 17–18.
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15. Osime OC, Okojie O, Osadolor F, et al. Current practices and medico-legal aspects of pre-operative consent. East Afr Med J 2004; 81(7): 331–335. 16. UK Department of Health. Good practice in consent implementation guide: consent to examination or treatment. London: Department of Health, 2001, https://www.gov.uk/government/organisations/department-of-health 17. Schenker Y and Meisel A. Informed consent in clinical care: practical considerations in the effort to achieve ethical goals. JAMA 2011; 305(11): 1130–1131. 18. Fink AS, Prochazka AV, Henderson WG, et al. Predictors of comprehension during surgical informed consent. J Am Coll Surg 2010; 210(6): 919–926. 19. Howlader MH, Dhanji AR, Uppal R, et al. Patients’ views of the consent process for adult cardiac surgery: questionnaire survey. Scand Cardiovasc J 2004; 38(6): 363–368. 20. Moazam F. Families, patients, and physicians in medical decision making: a Pakistani perspective. Hastings Cent Rep 2000; 30(6): 28–37. 21. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Arch Surg 2000; 135(1): 26–33. 22. Joolaee S and Hajibabaee F. Patient rights in Iran: a review article. Nurs Ethics 2012; 19(1): 45–57. 23. Joolaee S, Tschudin V, Nikbakht-Nasrabadi A, et al. Factors affecting patients’ rights practice: the lived experiences of Iranian nurses and physicians. Int Nurs Rev 2008; 55(1): 55–61. 24. Joolaee S, Nikbakht-Nasrabadi A, Parsa-Yekta Z, et al. An Iranian perspective on patients’ rights. Nurs Ethics 2006; 13(5): 488–502.
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