Informed consent and responses of surgical patients: A study in North India

Background: A patient’s decision about his or her treatment without being pressurized by their health-care provider is his right and termed as autonomy. Informed consent means that a patient is not merely signing a paper but the whole process in which he is imparted knowledge regarding his disease, diagnostic options, and details regarding intervention modalities for his/her condition. As informed consent is patient’s right and key to trust/relationship between doctor and patient, it is imperative that consent is in layman’s language and the process is completely understood and appropriately documented. In India, there are very less studies conducted for the informed consent. Aims and Objectives: With this background, the present study was conducted in a tertiary care hospital at Patiala, Punjab, with the objectives – (1) to determine levels of awareness and understanding regarding contents of informed consent and (2) to analyze the patient’s perspective of the process of informed consent in a tertiary care hospital setting. Materials and Methods: A cross-sectional survey was carried out among the patients who had undergone elective or emergency surgery in the surgical departments of general surgery, obstetrics and gynecology, orthopedics, otolaryngology, ophthalmology, urology, and plastic surgery at a tertiary care teaching hospital at Patiala, Punjab, during October–December 2013. Around 400 post-operative randomly selected patients were interviewed using pre-structured questionnaire. Permission was obtained from the Institutional Ethics Committee. Results: A total of 400 post-operative patients were randomly selected for this study. Patients himself/herself responded in 60.5% of cases. Only 255 (69.29%) knew about proposed procedure, while 122 (33.15%) were informed about alternate treatment. Almost half (n = 170, 46.19) of them received information about type of anesthesia and only 51 (13.48%) were informed about its complications. In 32 (8%) cases, patients perceived that no informed consent was taken although record was available of the same. Conclusion: Informed consent enjoys an irrefutable position in clinical practice as a safeguard of patient’s rights. It also minimizes the chances of legal action against the treating physician if a complication arises from the proposed therapy. There is a dire need to alert the doctors and health-care providers.