Informed Consent In Tertiary Care Hospitals Of Pakistan; The Moral Magic Of Consent

Abstract

Objective: This study aimed to assess whether standard international guidelines obtain informed consent and to identify potential contributing factors.

Methodology: This Questionnaire descriptive cross-sectional study was conducted at public sector hospitals of Karachi (October 2021-Aug. 2022) after ethical approval.  A 12-point questionnaire was developed based on three categories, first to assess awareness & significance of IC, second regarding elements of IC & third for administrative part of IC.  Indoor adult patients ≥18 years of age, who have undergone any surgical or medical procedures were included. The critically ill, unconscious and those unable to give consent were excluded. Data was analyzed by SPSS version 23.

Results: A total of 587 subjects were included, with a mean age of 43. There were 340(57.9%) males & 247(42.1%) females. 51.7% of respondents had an education level of <10 years. 51.1% & 48.9 % of subjects underwent medical related & surgical related procedures respectively. 426(72.6%) patients were aware of IC and 318(54.2%) responded affirmative to significance of IC. 407(69.3%) subjects were informed about treatment options prior to procedure, 349(59.5%) were informed about complications, while risks & benefits of procedure were discussed with 294(50.1%). 281(47.9%) of the patients were satisfied with the information about the procedure, and 288(49.1%) subjects understood the information. Of the respondents, 356(60.6%) stated that the language used wasn’t appropriate for comprehension, 200(34.1%) identified language as a barrier, 185(31.5%) pointed to cultural factors, and 202(34.4%) believed that both language and culture were barriers to IC. 368(62.7%) of the subjects signed the IC, while the IC was signed by a family member in 219(37.3%). Only a minority of patients, 199(33.9%), felt that the consent process was free and fair, while 388(66.1%) believed their decision was influenced. Among them, 233(39.7%) felt influenced by the doctor, and 155(26.4%) attributed the influence to a family member.

Conclusion: There is significant room for improvement in achieving legally and ethically valid informed consent (IC). Literacy, language barriers, and cultural beliefs are major factors influencing patient’s understanding of IC. Higher levels of education were associated with better comprehension of IC.  The majority of patients reported that the consent process was neither free nor fair, with language and cultural barriers being significant obstacles. Enhancing the communication skills of healthcare professionals and incorporating formal training on obtaining IC at all levels, from undergraduate education to consultant training, is suggested.