Abstract
Introduction:
The surgical informed consent (IC) process is essential for respecting patient autonomy and safeguarding patients and healthcare providers. However, in many low- and middle-income countries, including Nepal, IC is often treated as a formality, with limited patient involvement and frequent reliance on caregiver-led consent. Cultural norms, poor communication, and lack of standardized protocols contribute to misunderstandings and dissatisfaction.
Aim:
To assess the satisfaction of patients and caregivers with the surgical IC process.
Methods:
This cross-sectional study was conducted at a government tertiary-level teaching hospital. It included 368 consecutive Nepali-speaking patients undergoing major elective surgeries across surgical departments. Demographic data were collected, and a structured, pretested questionnaire was used to assess the satisfaction and understanding among patients and caregivers. Descriptive statistics (frequencies, percentages, means, SDs) were calculated. Comparative analyses were conducted using t-tests or one-way ANOVA. For non-normally distributed variables, Spearman’s correlation was applied. Regression analysis was used to identify factors influencing patient and caregiver satisfaction.
Results:
In total, 86.4% of patients and 90.8% of caregivers were satisfied with the IC process. Caregivers had a significantly higher understanding of the nature (95.1% vs. 88%), indication (98.9% vs. 82.1%), and potential complications of surgery (87.5% vs. 68.5%) compared to patients. Patients with primary education or higher had significantly higher satisfaction scores than illiterate patients (P = 0.019; 95% CI: 0.16–2.61).
Conclusion:
Although patient participation in the IC process was limited, both patients and caregivers reported high satisfaction, suggesting cultural acceptance of caregiver-led consent in Nepalese hospitals.
Keywords: caregivers, informed consent, patient rights
HIGHLIGHTS
The study demonstrated high satisfaction rates among patients and caregivers with surgical informed consent.
Literate patients had significantly higher satisfaction scores.
Standardized protocols for recording anesthesia-related complications and the identity of consent collectors should be prioritized.
Introduction
Informed consent (IC) in surgery enables patients with autonomy in decision-making, serves to protect patient rights, and safeguards the surgical team[1]. However, patients have different levels of comprehension of this process, with many undergoing surgical interventions without even knowing the objectives of the surgery. Signing an IC form does not necessarily indicate that a patient fully understands the risks associated with the procedure[2]. Evidence suggests that if the consent process is communicated properly, patient satisfaction levels are higher perioperatively[3]. Despite its ethical and legal importance, studies have consistently reported inadequacies in the IC process. A national medicolegal database from the U.S. reported that 65.6% of malpractice claims were due to failure to obtain IC, with the most common issues being the inadequate explanation of risk and adverse effects and the failure to offer alternative treatment options[4]. In developed countries, legal implications have led to a more protocol-driven approach[4,5]. However, such protocols are lacking in developing countries.
Patient expectations vary based on socio-cultural norms[5,6]. Studies from developing countries show that patients view written consent as ritualistic and bureaucratic, and some even feel pressured to give consent[7]. In many LMICs, including Nepal, the IC process is taken as a mere formality. Studies from South Asia and sub-Saharan Africa have shown that patients frequently view written consent as a bureaucratic task rather than a meaningful dialogue[5,7–9]. In such settings, decisions are commonly made by family members or entirely by healthcare professionals, due to sociocultural norms that prioritize family consensus over individual autonomy[10,11].
In our institution, IC is frequently obtained from caregivers of the patient, with minimal involvement of patients, in the inpatient ward, the night before surgery. This practice is partly to minimize patient anxiety, but it raises questions about whether patients’ rights and preferences are being respected[3]. The need to improve communication and consent practices in Nepal is further underscored by rising incidences of violence against healthcare workers. A recent study in Nepal attributed these conflicts to inadequate staffing, heavy workloads, and poor communication[12]. This study seeks to answer the research question: How satisfied are patients and caregivers with the surgical IC process in a Nepalese tertiary care setting, and how acceptable is the current caregiver-led consent model to them? By evaluating the quality and clarity of information provided during the process and exploring the preferences of both patients and caregivers, we aim to generate insights that can inform culturally appropriate improvements in consent practices.
Materials and methods
Study design
This was a cross-sectional study conducted in accordance with the ethical guidelines of the Declaration of Helsinki 2013 and reported following STROCSS guidelines[13].
Study area and period
The study was conducted at a government tertiary-level hospital in Nepal, where approximately 100 major surgeries are performed monthly. Data were collected over 3 months (October–December 2024) in the surgical wards of General Surgery, Neurosurgery, Plastic Surgery, Urology, Ear–Nose–Throat (ENT), Orthopedics, and Obstetrics and Gynecology departments.
Sample size determination
The sample size was calculated using the single population proportion formula:
n = (Zα/2)2p (1-p)/d2
Assuming a 50% prevalence rate (P = 0.50) of proper IC practices – chosen to yield the maximum required sample size in the absence of prior data from similar socio-cultural settings in Nepal – a 95% confidence interval (Z = 1.96) and 5% margin of error (d = 0.05) were used. This gave a final sample size of 384 patients.
Sampling procedure
We employed consecutive sampling, enrolling all eligible patients and their caregivers undergoing major elective surgeries during the study period. This approach was selected due to the practical challenges of conducting true random sampling in a high-turnover inpatient surgical setting, ensuring feasibility while minimizing selection bias.
Inclusion and exclusion criteria
All patients who underwent major elective surgical procedures and their caregivers were included. Major surgery was defined as surgeries requiring regional or general anesthesia. For patients <18 years old, only caregivers’ data were included. Patients were excluded if they were operated on an emergency basis, could not converse fluently in the Nepalese language, caregivers were unavailable for the interview, were readmitted, or did not provide consent.
Caregivers were defined as the adult family members or legally authorized individuals who accompanied the patient during hospitalization and were involved in the decision-making process regarding the patient’s surgical care.
Study tool
A structured and pretested questionnaire was used. The tool was developed based on prior studies[4,11,12]. It included the demographic details of patients and caregivers, the components of the IC (13 questions), the type of information provided (9 questions), a 10-point Likert scale to measure satisfaction with the IC process, and the structure of the consent form (7 questions). The questions were asked separately to patients and their caregivers to assess their perspectives independently. A pilot test was conducted on 5% of the sample size (n = 18) to refine the tool. Internal consistency of the Likert-scale questions was assessed using Cronbach’s alpha, yielding a reliability score of 0.81, indicating good internal consistency.
Data collection
Data were collected using a predesigned proforma, with all information recorded by three interns who were oriented about the study. Interviews with patients were conducted in the waiting area of the operating theatre (OT) just before they were taken for the surgery. Similarly, interviews with the patient’s caregiver, who had provided consent, were conducted after the patient was taken to the OT. All the interviews were conducted in the local language (Nepalese). The IC form was evaluated after the interview.
Variables
The dependent variable was the patient and caregiver satisfaction with IC, while the independent variables were age, sex, education level, and the department.
Outcome
The primary outcome was satisfaction with the surgical IC process among patients and caregivers, assessed by satisfaction rates and comparison of mean satisfaction scores across patient and caregiver groups. Secondary outcomes were identifying predictors of satisfaction among patients and caregivers, and assessing completeness of documentation in IC forms.
Data processing and analysis
The collected data were entered into Google Spreadsheets and then exported to the Statistical Package for the Social Sciences (Windows version 26) for further analysis. Descriptive statistics, such as frequency, percentage, median, and standard deviation, were used to describe the study population. Satisfaction scores were rated from 1 to 10 (1 representing lowest, 10 representing highest). The comparison of means was conducted (independent sample t-test or one-way ANOVA test, wherever applicable) to assess the association between each independent variable and the patient satisfaction score on IC. For non-normally distributed variables, Spearman’s correlation was applied. Binary logistic regression was performed to identify potential predictors of satisfaction. Statistical significance was set at P < 0.05.
Ethical consideration
Ethical clearance was obtained from the Institutional Review Committee of the Institute of Medicine (Reference number: 225-6-12, ClinicalTrials.gov registration number NCT06746207). To minimize potential coercion, all participants were explicitly informed that their decision to participate – or not – would not affect their care. Interviews were conducted privately, ensuring a comfortable setting away from clinical staff. Written IC was obtained, and participants were assured of confidentiality, anonymity, and the right to withdraw at any time.
Results
Of the 422 eligible patients, 368 (87.2%) consented and were included in the final analysis.
Socio-demographic characteristics
The mean age was 39 years (+4.69 SD, range 2–81 years), and the male-to-female ratio was 1:1. The majority of caregivers were sons (24.5%). Most patients could not read or write (73.9%) (Table 1).
Table 1.
Sociodemographic characteristics of the study respondents (n = 368)
| Variable | Frequency (percentage) |
|---|---|
| Mean, SD Age (in years) | 39, 4.69 |
| Sex | |
| Male | 184 (50) |
| Female | 184 (50) |
| Caregiver (relation to patient) | |
| Husband | 68 (18.5) |
| Wife | 32 (8.7) |
| Father | 74 (20.1) |
| Mother | 8 (2.2) |
| Son | 90 (24.5) |
| Daughter | 32 (8.7) |
| Other | 64 (17.4) |
| Patient’s education | |
| Could not read or write | 272 (73.9) |
| Primary (1–5 years of schooling) | 18 (4.9) |
| Secondary (6–10 years of schooling) | 16 (4.3) |
| Intermediate and above (>10 years) | 62 (17.9) |
| Caregiver’s education | |
| Could not read or write | 56 (15.2) |
| Primary (1–5 years of schooling) | 78 (21.2) |
| Secondary (6–10 years of schooling) | 18 (4.9) |
| Intermediate and above (>10 years) | 216 (58.6) |
| Department | |
| ENT | 12 (3.3) |
| Ophthalmology | 6 (1.6) |
| General surgery | 34 (9.2) |
| Gastrointestinal surgery | 32 (8.7) |
| Gynecology/Obstetrics | 18 (4.9) |
| Neurosurgery | 14 (3.8) |
| Orthopedics | 184 (50) |
| Plastic surgery | 24 (6.5) |
| Urosurgery | 44 (12) |
Patient and caregiver understanding of IC
In total, 86.4% of patients and 90.8% of caregivers were satisfied with the IC process. Caregivers had a significantly better understanding of consent, the nature, indication, and complications of surgery compared to patients. Furthermore, caregivers had a significantly better understanding of long-term effects and necessary lifestyle changes, received examples of similar cases from the surgeon, and had more questions during the consent process compared to patients (Table 2).
Table 2.
Responses to the questions on the nature of the informed consent
| Information | Patient frequency (percentage) | Caregiver frequency (percentage) | Chi-square | P-value |
|---|---|---|---|---|
| Was the consent taken? | ||||
| Yes | 338 (91.8) | 362 (98.4) | 16.8 | <0.05a |
| No | 30 (8.2) | 6 (1.6) | ||
| Were you informed of the nature of the surgery? | ||||
| Yes | 324 (88) | 350 (95.1) | 11.9 | <0.05a |
| No | 44 (12) | 18 (4.9) | ||
| Were you informed of the indication for surgery? | ||||
| Yes | 302 (82.1) | 364 (98.9) | 60.7 | <0.05a |
| No | 66 (17.9) | 4 (1.1) | ||
| Were you informed of the possible complications of surgery? | ||||
| Yes | 252 (68.5) | 322 (87.5) | 38.8 | <0.05a |
| No | 116 (31.5) | 46 (12.5) | ||
| Were you informed of long-term effects and lifestyle changes after surgery? | ||||
| Yes | 166 (45.1) | 196 (53.3) | 4.9 | 0.026a |
| No | 202 (54.9) | 172 (46.7) | ||
| Were you given examples of previous similar surgeries by the surgeon? | ||||
| Yes | 168 (45.7) | 206 (56) | 7.8 | 0.005a |
| No | 200 (54.3) | 162 (44) | ||
| Did any questions arise during the process of informed consent? | ||||
| Yes | 184 (50) | 214 (58.2) | 4.9 | 0.026a |
| No | 184 (50) | 154 (41.8) | ||
| Did informed consent influence your decision to undergo surgery? | ||||
| Yes | 12 (3.3) | 16 (4.3) | 0.59 | 0.44 |
| No | 356 (96.7) | 352 (95.7) | ||
| Are you in favor of informed consent? | ||||
| Yes | 340 (92.4) | 344 (93.5) | 0.33 | 0.56 |
| No | 28 (7.6) | 24 (6.5) | ||
| Are you satisfied with the information provided for informed consent? | ||||
| Yes | 318 (86.4) | 334 (90.8) | 3.44 | 0.06 |
| No | 50 (13.6) | 34 (9.2) |
Significant P-value.
Predictors of satisfaction scores
Patient satisfaction scores
Patients with primary education and higher had significantly better satisfaction scores than those who were illiterate (P = 0.019, 95% CI: 0.16–2.61). Patients undergoing gastrointestinal surgery had significantly higher satisfaction scores than those undergoing orthopedic (P = 0.028, 95% CI: 0.09–2.91) and plastic surgery (P = 0.043, 95% CI: 0.03–3.97). A Spearman correlation analysis between patient age and satisfaction scores revealed no significant correlation.
Caregiver satisfaction scores
The satisfaction of caregivers was significantly influenced by the department (P < 0.05). There were significant differences in satisfaction scores between several departments, general surgery and orthopedics (P = 0.006, 95% CI: 0.27–2.77), gastrointestinal surgery and orthopedics (P = 0.001, 95% CI: 0.48–2.79), gynecology and orthopedics (P = 0.017, 95% CI: 0.17–3.12), and urology and orthopedics (P < 0.05, 95% CI: 0.57–2.61). No significant associations were found between the satisfaction scores and the education level of the caregivers or the sex of the patient.
Analysis of IC forms
The IC form included the patient’s name (97.3%), the procedure name (90.2%), diagnosis (88.6%), risks of the procedure (98.4%), and the caregiver’s signature or thumb impression (90.8%). Documentation of anesthesia and consent collectors was noted in 33.7% and 26.6% (Fig. 1).
Figure 1.
Bar graph showing the information in the IC form.
Discussion
One-fifth of the patients were not informed about the indication for surgery, and one-tenth were unaware of consent. This finding is consistent with literature from other countries, where it is common for relatives, rather than patients, to sign consent forms[3,14]. The decision-making process in our setting remains largely unilateral, in contrast to Western healthcare systems. There was limited active participation of patients and caregivers during the IC process, with approximately half of the patients and caregivers raising questions. Barriers such as the perception of doctors being “busy” or “short-tempered” may discourage patients from engaging actively[15]. Healthcare providers should create environments where patients feel encouraged to ask questions and express concerns.
Interestingly despite low participation in the consent process, the satisfaction scores among patients and caregivers were high. The satisfaction rate was higher than that reported in prior studies (43%–80.8%)[3,16,17]. The majority of patients were satisfied with caregivers providing consent on their behalf. In contrast to a previous study where IC was delivered by nurses (68.6%), in our case, all ICs were administered by surgery residents[3]. As residents are expected to have a higher understanding of the procedure, detailed explanations of potential complications and the surgical process might have led to higher satisfaction among patients and caregivers. Training programs from surgical residency should emphasize and reinforce communication skills and patient engagement to enhance the quality of the IC process[18]. In contrast, Samaranayake et al, however, suggested nurses be more approachable than doctors while administering the consent form[5].
The results indicated that caregivers had significantly higher comprehension of surgery compared to patients. This may be because of the lower literacy level of the patients (73.9% illiterate) compared to caregivers (15.2% illiterate). This finding contrasts with that of a previous study reporting that patients who signed the consent form themselves were more informed about the nature of the surgery as compared with the relatives who signed on the patient’s behalf[3]. Despite the equal representation of male and female patients undergoing surgery, caregivers had a significantly higher proportion of males (63.1%). This disparity may be attributed to traditional gender roles and the limited involvement of women in decision-making. In many cases, the male head of the household assumes responsibility for important decisions, including providing IC, further reflecting the gender dynamics in healthcare decision-making[5].
Patients with a primary level of education or higher had significantly greater satisfaction with the IC process compared to illiterate patients, highlighting the role of educational status in shaping patients’ ability to understand and engage with medical information[19]. Notably, patient age and sex did not correlate with satisfaction scores, similar to findings from previous studies[20,21]. Additionally, patients undergoing gastrointestinal surgery reported significantly higher satisfaction scores than those undergoing orthopedic and plastic surgeries. Caregiver satisfaction with the IC process was significantly influenced by the surgical department, with notable differences observed between orthopedics and other departments. Caregivers of patients undergoing procedures in departments other than orthopedics consistently reported higher satisfaction levels. This variation may reflect departmental differences in communication practices, time for consent discussions, or how consistently surgical teams address patients’ informational needs.
One significant area for improvement is the documentation of the IC process. In our study, while 98.4% of forms mentioned procedural risks, only 26.6% included information about anesthesia-related complications, similar to that reported in prior studies[2,14]. This may be due to a lack of clear delegation of this task between surgeons and anesthesiologists. Moreover, only one-fourth had the identity of consent collectors, and half of the consent forms lacked the patient’s signature or thumb impression. This aligns with previous research on IC documentation deficiencies[15], highlighting the inadequacy of the consent forms of crucial aspects, which can have serious legal consequences. Standardized protocols for recording anesthesia-related complications and the identity of consent collectors should be prioritized.
Although previous studies have explored the IC process more generally, this study is, to our knowledge, among the first to specifically assess satisfaction with surgical IC in a tertiary care setting in Nepal. Moreover, by incorporating perspectives from patients and their caregivers, our study provides a more comprehensive understanding of how the current caregiver-led consent model is perceived, an area that has been largely overlooked in existing literature. This study reveals considerable gaps in the documentation of IC, particularly concerning anesthesia details and the identity of the person obtaining consent. To address these issues, we recommend standardized consent forms that include dedicated sections for surgical risks, anesthesia information, and the name and designation of the consent collector. Periodic audits and feedback mechanisms could also be implemented to monitor compliance and drive continuous improvement in documentation standards.
Limitations
This study has limitations. One notable limitation is that patients and caregivers were aware of the ongoing research, which may have influenced their responses (Hawthorne effect). The study relied on self-reported satisfaction scores. Social desirability bias is also a potential limitation. While the structured quantitative approach allowed for systematic comparison, it may have lacked the depth needed to capture nuanced personal experiences and perceptions that a qualitative or mixed-methods design could have provided. Since the research was carried out in a government hospital, care should be taken when applying the results to private and semi-private hospitals due to potential differences in patient groups and practices.
Conclusion
Despite minimal participation of patients in the consent process, there were high satisfaction scores among patients and caregivers for surgical IC, with literate patients having higher satisfaction scores. This suggests that the practice of having surgery residents administer IC from caregivers is effective and culturally contextual in the Nepalese setting. The current inconsistencies in the documentation, especially regarding surgical and anesthetic risks, highlight the urgent need for standardized consent forms that include dedicated sections for surgical risks, anesthesia information, and the name and designation of the consent collector.
Footnotes
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Published online 10 June 2025
Contributor Information
Prajjwol Luitel, Email: drprajjwolluitel@gmail.com.
Sujan Paudel, Email: paudelsujan1824@gmail.com.
Nischal Neupane, Email: nischalneupane2020@gmail.com.
Abhishek Kumar Shah, Email: shahabhi61@gmail.com.
Pawan Sapkota Upadhya, Email: intellectsite2@gmail.com.
Anup Thapa, Email: anup.thapa@naihs.edu.np.
Ethical approval
Ethical clearance and permission letters were obtained from the Institutional Review Committee of the IOM (IRC application number: 225-6-12). Prior to enrollment, patients provided informed consent. To maintain confidentiality, patient information was safeguarded. The study protocol conforms to the ethical guidelines of the Declaration of Helsinki 2013.
Consent
Written is consent obtained from all patients for publication and any accompanying images, a copy of which is available for review by the Editor-in-Chief of this journal on request.
Sources of funding
This study received no funding.
Author contributions
Declaration: All authors declare that the information provided is accurate to the best of their knowledge. Conceptualization: P.L., S.P., N.N., A.K.S., A.T. Patient Management: P.L., S.P., N.N., A.K.S., A.T. Writing – original draft: P.L., S.P., N.N., A.K.S., A.T. Writing – review & editing: P.L., S.P., N.N., A.K.S., P.S.U., A.T. Visualization and Supervision: P.L., S.P., N.N., A.K.S., A.T.
Conflicts of interest disclosure
There were no conflicts of interest among all authors.
Research registration unique identifying number (UIN)
The registration number for ClinicalTrials.gov is NCT06746207.
Guarantor
Prajjwol Luitel.
Provenance and peer review
Not applicable.
Data availability statement
The datasets used during this study will be available from the corresponding author upon reasonable request.
Acknowledgement
None.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used during this study will be available from the corresponding author upon reasonable request.