Twelve patients from general surgery, orthopedics and gynecology/obstetrics departments were participated on the in-depth interview (Table 1) and two FGDs were conducted on health professionals in this study.
3.1. Barriers during preoperative informed consent process from patients’ perspective
Almost all the study participants identified that inadequate explanation about the intended procedure as a main barrier during the ICP. “They (HCPs) didn’t give me any information about the planned surgery but they said that just you have to sign to confirm your agreement for anesthesia and surgery. I agreed and consented because it was not more than the bullet injury I am suffering. This was the only problem of the doctors. I understand that they are very busy ….” (A 27-year-old male patient who had intramedullary nailing). The other participant explained lack of adequate information for consent as “They asked me to sign on the consent form. I signed with fingerprint after discussing with myself. No one told me why and how my finger should be cut….” (A 38 year-old male patient who underwent amputation).
The other frequently raised barrier by participants was the interference of family members on the decision of the patient. Some family members intend to decide on behalf of the patient. The following barriers were also identified by the participants: anxiety, fear of light/power interruption during surgery, inadequate time for discussion and not letting the family members during ICP.
Suggested solutions by patients
Most of the participants suggested HCPs to provide adequate information both for the patient and the family members, understanding patient’s condition (e.g., anxiety and pain) and providing adequate time to discuss with family members and decide.
“… so, information has to be given for the patient as well as for the family. Patient should sign voluntarily and the family should be available” (a 26-year-old male patient who underwent external fixation of left leg)
3.2. Barriers during informed consent process from HCPs perspectives
We conducted one Focused Group Discussion with general surgeons, orthopedic surgeons and gynecologists/obstetricians (2 participants from each). The discussion took 48 minutes. We omitted the sociodemographic data of the participants to insure the confidentiality
Various challenges and solutions were discussed in detail with the study participants. The main barriers identified by the participants frequently includes: inability of patients to understand the information, limited time to explain the risks and benefits of planned procedure, poor written informed consent form, poor awareness of patients/community about surgery, fear of patient refusal for surgery if risks explained and associated health problems, lack of adequate investigations to confidently explain about the disease, poor documentation habit of HCPs, lack of legal system that help HCPs during difficult situations like in ethical dilemmas, lack of attention by HCPs for the informed consent process and related consequences, fear of patients to request the proposed procedure if they changed their mind after refusal for the procedure and informed consent being obtained by not the operating/senior surgeon.
“Fear of patient refusal for surgery if we explained the risks of operation. Lack of time during emergency conditions. The consent form is very short and it does not give adequate information. You can tell them orally but they can deny later in case any complication happens.” (gyn/obs specialist).
The proposed solutions by the participants includes: creating awareness for patients, HCPs, and for the community using different media, providing adequate time for the patients to discuss and decide, establishing a legal system that supports HCPs when they encounter ethical dilemmas, being a role model for students, the operating/senior surgeon should be available during informed consent process, HCPs need to be patient friendly and explain risks and benefits carefully considering the level of health literacy and documenting the information delivered.
“Regrading patients; we need to give them health education, the media also should give coverage to create awareness (TV & radio), and health extensions also need to work on this issue to improve health literacy. The legal issue needs great emphasis especially for incapacitated patients. In our setup we let go the patient if the proxy of the incapacitated patient is refused to consent. But ideally the medical board or legal support can decide to proceed for the surgery. But no one is doing this method in our set up. Regarding medical ethics education there is improvement in medical education. There are different courses on ethical issues. But theory could not improve the performance of future graduates. So, we need to be exemplary during our practice.” (One of the general surgeons)
Similarly, we conducted another FGD with anesthesia professionals which took 50minutes duration. The main barriers raised by anesthetists include: use of medical jargons, fear of patient refusal, cultural and family influences on patients’ decision, inability of HCPs to check whether the patient has understood the given explanation, lack of standardized informed consent form, poor awareness of patients about anesthesia, inability of HCPs to explain risks and benefits of proposed anesthesia plan, urgency of procedure/shortage of time, inability to understand patients’ condition (lack of empathy), fatigue of HCPs and incapacitated patients to give consent.
“Some professionals use informed consent as a frustration tool for the intention not to do the operation. This is lack of empathy …” (participant III)
“Even though I know the risks of having the operation I ignore letting the patient know the risks due to fear of patient understanding. I do have one experience regarding informed consent; one of my patients refused to take spinal anesthesia, then I told him some of the minor side effects of general anesthesia and obtained informed consent for GA. Then, I gave him GA as per his request. Unfortunately, he developed severe complications during the operation. It was very difficult if he died or had severe consequence” (participant III)
The anesthetists also suggested the following solutions: creating awareness to patient, anesthesia professionals and community (“Patients may perceive that signing informed consent is agreeing for death (providing adequate explanation to the patients’ level of understanding). It is also important to improve the attitude of professionals regarding informed consent.”), doing audit on the practice of informed consent to identify gaps, developing standardized informed consent form, providing training for anesthetists to bridge knowledge gap and improve documentation of conversations.
“… as a result, better to understand patients’ disease condition and explain the information to their level of understanding ….” (Participant II)
“… so, based on this experience I learnt that we should not only explain the risks and benefits, but also, we have to document our conversations to avoid ethical and legal problems related to anesthesia.” (Participant III)