Overview and definitions
Informed consent (IC) is a legal and ethical document that represents one of the fundamental rights of patients in health care. Informed consent “is probably the most revolutionary, the most rudimentary, the most misunderstood and misused term in all of health law and bioethics” [1]. The patients’ rights movement has been working on establishing an intercorrelated relationship between patients and healthcare providers (HCPs) to ensure that patients are aware of health-related information, receive the required education, and are familiar with their social rights [2]. Moreover, patient rights emphasize equal access to healthcare by all patients as well as compliance of the HCPs with ethical standards in the required care provided to patients [3]. This includes having patients’ rights standards based on the type of service provided by the health care facility. For example, if there is no surgery unit, a consent form will not include a section for this service [3].
The general concept of patient IC involves “voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and medical and surgical treatment” [4]. IC guarantees patient autonomy in choosing the preferred treatment with adequate knowledge regarding the surgery to be performed [5,6,7]. The process of obtaining IC should ensure that the patients understand the treatment, care, services, and procedures they will have to undergo [8]. Furthermore, IC is considered as a legal document that protects HCPs from legal liability [9].
This study focuses on surgical informed consent (SIC) as a distinct type of the IC and its role in enhancing patients’ experience, improving patient satisfaction, and improving the quality of services [6, 10]. The SIC is defined as “a client’s right to receive adequate and pertinent information that allows the client to fully understand the proposed surgery, including possible benefits and complications” [7].
Although SIC has been extensively studied in literature, the actual implementation is still lagging [7, 11, 12]. Information provided by the HCPs should be in a common and clear language and sufficient time should be allocated to allow the patients and/or their guardians to discuss unclear steps or information regarding the surgery [9]. A well-executed SIC signed by a patient who has been properly informed is essential to every surgical intervention [8].
Failure to obtain SIC undermines patient autonomy, lowers patient satisfaction, increases risk, and negatively affects the patient’s trust in the surgeon [12, 13]. If the surgical procedure results in an undesired outcome, the patient-physician relationship may deteriorate which could lead to an assault or battery [13, 15]. In addition, a lack of proper documentation of SIC may result in a physician being sued for disciplinary actions [4, 9, 14].
On a national level, the Patient Experience Centre in collaboration with the Patient Safety Centre in Saudi Arabia has published an IC manual for Saudi healthcare settings [16]. The ethical elements of IC information sharing involve ensuring that a patient understands the treatment plan, is aware of all available options, understands the importance of their opinions, and is an integral part of the team in shared decision making [16].
Surgical informed consent
Existing literature on SIC has reported smaller proportions of patients who feel that physicians provide them with all necessary information about their surgery [17, 18]. One study found a significant difference between physicians and patients reports of the amount of information provided regarding the surgery [18]. In this study, patients were asked for their opinions on the information they received during the outpatient visits before the surgery [18]. In fact, patients’ view before the surgery could affect their ability to evaluate the surgery information. However, this study has not reached a conclusion regarding the real quality of the entire SIC process [12].
The knowledge provided for the IC differed from one setting to another. Variations in the amount of information provided for surgery have been reported in previous studies. Kirane et al. (2015) and Weckbach et al. (2016) reported that little information was provided to patients regarding the surgery while Hallock et al. (2017) and Yildirim et al. (2014) reported that a large amount of information was provided [5, 19,20,21].
In other studies, patients reported receiving better verbal explanations about the planned surgery [22,23,24]. Ochieng et al. (2015) have concluded that even if the physician gives good verbal information about the surgery, only 50% of the physicians allocate a suitable time during the discussion to answer patients’ questions [23]. Furthermore, researchers have found that only 50% of the patients read the SIC form thoroughly [22]. Two studies have found that a high percentage of the patients could not recall the information provided to them [22, 25]. In addition, some patients reported they did not have sufficient time to sign the SIC given within 24 h before the surgery [22].
In obstetrics and gynecology, a study has reported that only 53% of the physicians discussed possible alternative treatments with the patient [26]. Although 94% of the physicians asked the patients whether they had any questions, only 32.7% confirmed that the patient understood the information by asking them to repeat it [26]. Furthermore, 90% of trainee physicians were not sure about the surgical risks involved when discussing the SIC with patients. However, most of the participants in this study were female physicians, which affects the generalization of the result from a gender perspective [26]. In general, physicians may be biased when they explain the benefits and potential risks of the proposed surgery [27].
Several studies have reported that only a low number of patients were dissatisfied due to physicians not explaining the required information [5, 22, 23]. In addition, one study reported a significant association between the information and awareness of SIC and the success rate of the operation and patient satisfaction [5]. Shemesh et al. (2019) have reported an association between high levels of education and employment status to patient satisfaction. However, no associations were identified between patients’ demographic characteristics and satisfaction in these studies [28].
A qualitative study by Gabay & Bokek-Cohen (2020) stated that patients prefer personalized information tailored to their needs [17]. While they argue that there is time available for discussion, it was found that physicians’ behavior regarding explanations was below expectation, both in terms of time and emotion [7, 24, 29, 30]. All these studies reported the importance of time spent on the SIC process. Other factors found to have effects on the SIC process are patient participation and parents’ involvement [24], patient education [24, 30], the environment, and the opportunity for clarification for the patient [7], and the amount of information provided [5, 29].
However, IC research is scarce in Saudi Arabia [31, 32]. One study found that 37% of the patients perceived IC to be a shared decision; 50% believed that it is to inform the patient; 45% think that it is to help the patient to decide; and 40% believe that it is to ensure that the patient understands the surgery [32]. However, the participants in this research scored their experiences within six months of having surgery. This can be viewed as a limitation of this study since such a long timeframe could affect the accuracy of patients’ recall of their experience. In a different study, researchers have found that only 54% of patients were satisfied with their experience, and almost 50% evaluated the quality of IC as poor [31].
Elective versus emergency surgery
Several studies found some differences in the SIC process for elective and emergency surgery. First, the overall quality of SIC was affected by the urgent nature of the surgery required [28]. Second, patients who undergo emergency surgery have less understanding than those who have elective procedures due to the urgency, the life-threatening nature of the patient’s condition, and the little time allocated for patient discussion [28, 30]. In Lemmu et al. (2020), most of the patients had had emergency surgeries, and there was no clear statistical comparison between the two groups [30]. The patients’ ability to recall the SIC process, and to read the SIC form, and patient satisfaction were low with emergency surgeries [29, 33].
One of the earliest studies comparing elective and emergency surgery patients was conducted by Khan in 2012 [29]. However, the surgery performed in the two groups differed, which affected the comparison due to the differences in the information obtained. Two studies conducted in obstetrics and gynecology settings found contradictory results [7, 34]. Teshome et al. (2019) found no statistical difference between emergency and elective cases [7], while Perić et al. (2018) had the opposite result [34]. Researchers identified patient illness, analgesic medication, and fatigue as factors associated with low patient comprehension in emergency surgeries [33, 34].
The previously discussed literature shows how SIC is currently practiced nationwide and on an international level. Furthermore, it shows that patients desire to be more involved in SDM. However, there is a clear gap between the information provided and the amount of information the patients want, as well as the level of involvement they prefer versus their actual level of involvement [17]. In Saudi Arabia, the literature seemed sparse, with only a few articles that discuss some aspects of the SIC process [31, 32, 35,36,37]. None of these articles addressed SIC for surgery in the inpatient setting. Obstetrics and gynecology settings are complex environments [38]. Thus, they should be examined.
This study explores and evaluates SIC for elective and emergency surgeries in the obstetrics and gynecology setting. This study will enrich the literature on SIC in Saudi Arabia. In addition, it will help to identify the weaknesses in the implementation of these concepts in practice. Finally, the study will guide improvement planning, based on the findings and that of other research in the local area in the obstetrics and gynecology field, which may differ from what has been found in other settings and countries.
This study focuses on the SIC process in obstetrics and gynecology settings. These topics were evaluated from the patients’ perspective. For the SIC, the issues discussed in the following section were considered.
These research data were obtained by eliciting patients’ recall of their experience during the SIC process for obstetric and gynecologic operations, which is considered to be an effective method to judge the SIC process [8]. The obstetrics and gynecology setting was selected because it has not been widely covered in the literature, compared to other specialties. Furthermore, this specialty may be different because of the urgency of some operations, such as under conditions that are considered to be potentially life-threatening to the patient or the fetus during pregnancy and delivery [39]. This study aimed to assess the experience of the SIC process from the patient’s perspective both for emergency and elective surgeries in obstetrics/gynecology in Saudi Arabia.
link