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ORIGINAL ARTICLE
Year : 2015  |  Volume : 12  |  Issue : 1  |  Page : 45-50

Knowledge, attitude and perception of patients towards informed consent in obstetric surgical procedures at Aminu Kano Teaching Hospital


Department of Obstetrics and Gynaecology, Bayero University/Aminu Kano Teaching Hospital, Kano, Nigeria

Date of Web Publication8-May-2015

Correspondence Address:
Abubakar Idris Sulaiman
Department of Obstetrics and Gynaecology, Bayero University/Aminu Kano Teaching Hospital, Kano
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0331-8540.156688

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  Abstract 

Background/Aim: The practice of informed consent prior to any surgical procedure should form the fundamental element that serves to protect both patient and surgeon from prosecution. The aim of this study was to assess knowledge, attitude and perception of women towards informed consent prior to Surgery in Obstetrics and Gynaecology department of Aminu Kano Teaching Hospital. Materials and Methods: This was a cross-sectional study conducted among 398 women who had undergone surgery at the Obstetrics and Gynecology department of the Aminu Kano Teaching Hospital, Kano State, Nigeria. Data was obtained following surgery but prior to discharge and was analyzed using SPSS version 17. Results: Three hundred and ninety eight women were recruited. The mean age was 30.3 years ± 5.2. All respondents believed signing a consent prior to surgery was important and believed it was a legal document involved in decision making process. Ninety seven percent of the respondents were satisfied with the explanation given to them prior to the surgery however, 15.8% had some reservations to the explanations while 3% were not completely satisfied with the explanations. Conclusion: Awareness and knowledge of consent was high in this study and the respondents had positive attitude towards signing consent.

Keywords: Attitude, consent, Kano, knowledge, perception


How to cite this article:
Sulaiman AI, Ayyuba R, Diggol IG, Haruna IU. Knowledge, attitude and perception of patients towards informed consent in obstetric surgical procedures at Aminu Kano Teaching Hospital. Niger J Basic Clin Sci 2015;12:45-50

How to cite this URL:
Sulaiman AI, Ayyuba R, Diggol IG, Haruna IU. Knowledge, attitude and perception of patients towards informed consent in obstetric surgical procedures at Aminu Kano Teaching Hospital. Niger J Basic Clin Sci [serial online] 2015 [cited 2023 Feb 4];12:45-50. Available from: https://www.njbcs.net/text.asp?2015/12/1/45/156688


  Introduction Top


Ethical code within medicine has evolved overtime. In the past, a "doctor knows best" attitude was adopted by patients before any procedure [1] as universal acceptance of the physician`s procedure. In this concept, physicians do not reveal any information to their patients about their disease or treatment options. [1] It was in the last few centuries that pressure began to mount on physicians for information about diseases and treatment options by patients. Physicians began to disclose basic information without necessarily outlining all potential risks. [1]

The Nuremberg Trials of 1947 are regarded as the basis for the development of medical consent. [2] The Nuremberg Code of 1948 laid out the principle that "voluntary consent of the human subject is absolutely essential". [3]

Informed consent eventually emerged as legal and a right in 1972. This was as a result of series of legal cases in California in the 1950s [4] and in response to public outcry concerning unethical practices in the Tuskegee research. [5]

Informed consent is a legal term that is supported by jurisdiction and international laws. It is defined as "voluntary agreement given by a person or a patient's responsible proxy for participation in a study, immunisation program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits and risks." [6] It is based on the principles of autonomy and privacy. It has become the requirement at the centre of morally valid decision making in health care and research. [7]

Informed consent is governed by criteria that assumed the individual giving the consent has the competence of comprehending information and making a voluntary decision based on the medical information given. [7]

When an individual gives consent having being duly informed, he/she is said to have given an informed consent. Where the individual however, rejects the information and refuses to give consent, he is said to have made an informed refusal. [7] It has influences that originated from basic bioethical principles (autonomy, beneficence, non-male ficence and justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki) as well as legal considerations pertinent to each community. [8]

In Nigeria, the doctrine of informed consent has become enshrined as a fundamental right under Section 37 and 38 of the 1999 Constitution. [9] Nigeria, in conformity with other international guidelines recognizes the need for informed consent in research and medical practice. [10],[11]

An ideal consent form for operation should begin with a brief explanation of the planned operation, including the type of anaesthesia involved. It is also good to tell the patient what she/he should experience during surgery, if under a local anaesthetic. [12] Patients should also be informed about the risks and benefits involved, any alternative treatment and the risks and benefits if nothing is done. [13],[14]

Current guideline states that the person obtaining informed consent for any surgical procedure must either be capable of performing the surgical procedure or has received specialist training in advising patients about the procedure. [13]

There is no time limit for validity of informed consent provided that the patient's conditions has not changed and/or new information about the proposed intervention or alternative treatment have not come to light within the intervening period. [15] In fact, the longer the interval between the time of obtaining informed consent and the definitive surgical procedure the better because the patient has understood all the risks, side effects and the benefits of the surgery in time and had had time to discuss all his fears and queries.

If a patient is within the legal age of consent (≥18 years in developed nation), but without the capacity to give consent, that person is legally incompetent to give consent. [16] In temporary loss of capacity, surgery could be deferred. In permanent loss however, surgery may proceed if felt to be in the best interest of the patient unless the patient had earlier refused the procedure before the loss of capacity. [12] Informed consent must be sought from the parent of a patient below 18 years of age without the capacity to give consent. [12]

Several factors influence patient`s decision making in informed consent. Sociocultural and religious beliefs affects patient`s decision making process. One of the strongest predictors of patient's comprehension during informed consent is knowledge. Educated patients are conscious of their rights and are more likely to understand and comprehend information on consent than uneducated individuals who are more likely to dwell on mystic beliefs. [17] Rajesh et al., showed that about 88% of patients believed they had no right to change their minds after signing consent and 61.6% trusted their doctor to do the right thing. [18] A study in Saudi Arabia had shown about 48% of patients signed consent because they thought the surgery would not be done if they did not and 42% thought they would lose a good relationship with their Doctor. [19]

Patient`s refusal to sign consent for surgical operations is not a common practice in Nigeria. [20] The fear of not waking up from surgery is the reason most respondents give for refusal to sign consent form. [7]

This study aims at assessing the knowledge, attitude and perceptions of patients towards informed consent for obstetric and gynecologic surgical procedures at Aminu Kano Teaching Hospital, Kano.


  Materials and methods Top


This was a cross-sectional study. Approval for the study was obtained from ethical committee of AKTH and informed consent from the clients was sought and obtained.

A pre-tested structured questionnaire was used to assess the knowledge, attitude and perception of women, who underwent either obstetrical procedure in AKTH between 1 st July and 30 th September, 2013. All consented postoperative women were recruited for the study within the study period until the required sample size was attained. Resident doctors in the department administered the questionnaires.

Data obtained from the questionnaire were entered into personal computer and analyzed using SPSS version 17 statistical software. Comparison of categorical variables was done using Chi Square test while P - values of 0.05 or less was considered significant.

Sample size estimation

The sample size formula used is as follows:

N = z 2 pq/d 2[21]

n = minimum sample size

z = standard normal deviate set at 95% confidence limit = 1.96

p = prevalence of Obstetric and Gynaecologic Surgical Procedures that required informed consent in a previous study.

Q = 1-p (complementary probability)

D = margin of error = 5% =0.05

Prevalence of Obstetric and Gynaecologic Surgical Procedures that required informed consent used in this study is 0.5 (50%) for we could not lay our hands on a similar prevalence Therefore;

P = 0.5

Q = 1-0.5

= 0.5

n = (1.96) 2 × 0.5 × 0.5/(0.05) 2

= 3.8416 × 0.25/0.0025

= 0.9604/0.0025

= 384.16

So the minimum sample size is 384.


  Results Top


Three hundred and ninety eight women were recruited for the study. The mean age was 30.26 ± 5.2 years. Ninety five percent of the respondents were married and 74.9% were house wives. Majority of the respondents were Muslims 356 (89.4%) while Christians constituted 42 (10.6%). Majority of the respondents 358 (89.4%) had formal education and 42 (10.6%) had non-formal education [Table 1].
Table 1: Socio-demographic characteristics of the respondents


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Of the 398 women, 57.8% had elective surgery while 42.2% had emergency surgery [Table 1]. A significant percentage (97.5%) was aware of consent while 2.5% never heard of it [Table 2]. For those who heard of it 37.2% heard it from media, 34.7% from friends and 26.1% new about it because they have signed it in the past.
Table 2: Knowledge of informed consent and the extent of respondents understanding of informed consent form


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A total of 272 of the respondents have signed consent in the past while 126 of the have not. Among those that have signed in the past, 224 (56.3%) signed themselves while 46 (11.6%) had their consent signed by relatives and only 2(0.5%) was signed by attending doctor.

The risk of surgery and anesthesia was explained to 374 (94%) and 366 (92%) of the respondents respectively while 22 (6%) and 32 (8%) had no explanation concerning any risk respectively. Explanation concerning the procedure was given Less than 24 hours before the procedure to 266 (66.8%) of the respondents while 132 (33.2%) had explanation more than 24 hours. Three hundred and eighty six (97%) of the respondents were satisfied with the explanation given to them prior to the surgery while 12 (3%) were not. Assurance that surgery would be performed by a particular doctor was given to 182 (45.7%) of the respondents while 216 (54.3%) had no assurance. Almost all of the respondents 398 (99.5%) felt the right surgical procedure was conducted for them [Table 3]. Interestingly all the respondent believed signing a consent form prior to surgery was important and believed it was a legal document involved in decision making process [Table 3]. An appalling number of the respondents 374 (94%) believed that involving their relatives in the decision making was important while 24 (6%) believed it was not. Three hundred and thirty five of the respondents believed that the explanation served its purpose while 63 believed it did not and adjustments like spending more time and making the form more readable and self- reported was better. There was a significant association between type of surgery and patient response to the explanation X 2 =12.316, P = 0.006.
Table 3: Respondents attitude and perception towards informed consent form


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  Discussion Top


The mean age of the respondents was 30.26 ± 5.2 years which is lower than 40.2 years in a study by Adisa et al., [15] in Ile-Ife, Nigeria. This could be due to differences in data collection and differences in age ranges. Majority of the respondents (89.4%) had formal education. Those with no formal education constituted only 10.6%. This is similar to the findings of Adisa et al., [15] and Ngim et al. [16]

Awareness of consent is high (97.5%) however, only 68.3% of the respondents have signed a consent before. This was similar to the finding of Nige in Enugu [21] Nigeria, where 70-95% of respondents had signed a consent form in the past. Patient`s refusal to sign consent form for surgical operations is not a common practice in Nigeria. [20] Our study did not record any of the respondents refusing to sign consent for operation. This may probably be due to the high level formal education among them and high level of awareness as well. Other studies however documented fears of not waking up from the surgery as the main reason most respondents give for refusal to sign consent for operation. [7]

In this study, 56% signed the consent themselves which was less than 75% reported by Adisa et al., [15] but higher than 5.6% reported by Bako et al., [22] in Maiduguri. The educational level of the respondents may explain the low response rate documented by Bako et al. [20],[22] This study signifies a good patient participation in the decision making process and also showed that education plays a role in signing consent. Educated patients are conscious of their rights and are more likely to understand and comprehend information on consent than uneducated individuals who are more likely to dwell on mystic beliefs. [17]

The study showed significantly high level of awareness (92%) of anaesthetic complication compared to the finding of only 15% by Adisa et al. [15]

Time spent in explaining surgery procedure and possible outcome could calm patients and reduce level of anxiety. In this study however, 66.8% of the respondents felt insufficient time was spent in explaining the procedure to them. This is similar to the studies of Marko et al., [23] and Burkes et al., [24] while others prefer shorter time of explanation with some preferring discussions to be made on the day of surgery. The respondents in this study were virtually indifferent on cadre of doctors performing surgery on them which was similar to the findings by Verslouis et al., [25] where majority of respondents do not understand the position of a residents in training. Almost all the respondents (97%) were satisfied with explanation given to them and significant number understood the language of communication. However, 15.6% believed making it self- reported and having to spend more time could calm down anxiety and worry. This satisfaction rate was higher than the findings of Ngim et al., [16] where only 48.4% were satisfied and this may be due to differences in sample size. There was a statistically significant association between type of surgery and patient response to the explanation (P = 0.006)


  Conclusion Top


Awareness and knowledge of consent was high in this study and the respondents had positive attitude towards signing consent form. Majority of the respondents believed informed consent is a legal document to be used in decision making. Surgeons spend less time with their patient explaining the procedure.

Recommendations

Surgeons should make out adequate time to explain surgical procedure and possible complications to patients before any surgical procedure.

To ensure less apprehension consent should be discussed with patients several days before surgery so that patients have opportunity to clear any area of doubt concerning their beliefs and perceptions.

There is need for more local studies to understand different community peculiarities in designing consent form within the confines of the Helsinki declaration.

 
  References Top

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    Tables

  [Table 1], [Table 2], [Table 3]


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