A systematic review was conducted to evaluate the informed consent processes for surgical procedures in trauma patients. Many articles have been published on the subject of informed consent; however, very few of these have focused on informed consent in trauma patients. Although 150 review articles were identified in our research, none addressed this issue.
The investigators identified eight studies for analysis, and found that trauma patients had poor recall of diagnosis, surgical procedures, risks and benefits, and complications. Written information, pamphlets, or videos had positive effects on patients’ understanding and satisfaction. Written information may improve patients’ knowledge more than oral information, and video information may improve patients’ comprehension more than written information. The investigators posit that video or interactive media improve patients’ comprehension and satisfaction. Furthermore, we found that many factors may affect patients’ comprehension during the informed consent process, including age, level of education, injury severity, and baseline knowledge. The methods of evaluating patients’ knowledge and comprehension varied, and the timing of this evaluation also was very different across studies. To our knowledge, ours is the first systematic review to study informed consent in trauma patients.
Treating trauma patients, especially severely injured patients, is beyond the scope of traditional emergency departments. Management of trauma patients necessitates dedicated team work and appropriate communication with patients or their proxies. A multidisciplinary trauma team that includes trauma surgeons, emergency medicine physicians, anesthesiologists, neurosurgeons, and orthopedic surgeons is essential. Comprehensive emergency medical services must be readily available for patients with serious trauma. Our research has shown that trauma patients have poor recall of information during the informed consent process. We attribute their poor recall to several factors. First, physical pain and emotional stress may have impacts on the informed consent process. Some studies reported that patients undergoing emergency surgery do not fully read or understand the consent form . These patients reported that they felt they had no choice about signing the consent form, regardless of its content, and felt fearful when asked to sign it. However, patients who had read and agreed with the consent form and whose healthcare providers had ensured that they understood it felt more satisfied than those who had not experienced this . Emergency surgery is frequently required by trauma patients; however, not all such patients require emergency surgery. Moreover, although many patients requiring emergency surgery or being managed in emergency settings share similar characteristics and face similar scenarios, we believe that the informed consent process is more problematic for trauma patients than for patients in other categories. Each trauma patient has unique characteristics and faces a unique scenario. They may have diverse types of injuries and those injuries may be complex and vary widely in severity, especially in patients who have sustained severe or multiple trauma. The content of information that should be imparted for different conditions may differ considerably and delivery of complete information may be challenging. All these factors may influence trauma patients’ comprehension and the informed consent process. Five studies that we reviewed were on orthopedic patients, one on individuals with nasal bone fractures, and another on individuals requiring trauma-related limb surgery. All these studies were conducted on less complicated, relatively stable trauma patient cohorts. Only one study was conducted in an emergency department. This may reflect the challenges of obtaining valid informed consent and conducting relevant research in trauma patients. Therefore, healthcare providers should more strongly prioritize patients’ comprehension. Obtaining valid informed consent from trauma patients should be ensured and this may well require a dedicated informed consent process.
Although informed consent is a critical issue for physicians, not all physicians recognize its importance in their clinical duties . In some studies, the administration and documentation of informed consent for surgical care were inadequate [49, 50]. Poor documentation of risks and complications revealed that patients might not have received appropriate information and that the consent might not have been valid [51, 52]. Another study revealed that the provision of pre-operative counseling for surgical informed consent in obstetric and gynecologic surgeries might not be comprehensive and standardized .
In our research, two studies reported that informed consent for surgical procedures was obtained by residents or chief residents [40, 46]. Residents may not have enough clinical experience to anticipate unforeseen treatment complications and risks. Furthermore, some residents may not have adequate communication skills to explain information in detail [54,55,56]. The information provided to patients may not be complete. Hence, patients’ needs may not be properly met by current principles of consent to treatment, particularly in emergency circumstances. One study recommended that a specific training program on obtaining consent for common orthopedic trauma procedures should be developed for junior doctors . Moreover, if a patient refuses a life-saving procedure in an emergency situation, junior residents may lack the confidence to handle the ethical dilemma .
One of the included studies reported that although the consent forms obtained from patients were adequate, trauma patients had poor information-recall scores. That study recommended preprinted consent forms, information sheets, and visual aids to improve patients’ retention and recall . One study also revealed that preprinted consent forms containing risks and benefits might improve the standard of informed consent . Another study revealed that the use of a procedure-specific label could improve the informed consent process and documentation as well as the communication between medical staff and patients . Although many hospitals have informed consent forms that include explanations of procedures, risks, and alternatives in detail, it should not be presumed that all patients can understand all the information provided on their case. Notably, one study reported concerns about the quality of informed consent forms, and found that the consent forms in use had communication deficiencies, particularly in describing risks . Moreover, such written consent is generally designed to protect clinicians and hospitals from litigation rather than for the benefit of patients [15, 62]. This fact is not concordant with the core values and principles of informed consent, and may be harmful to the patient–physician relationship. Therefore, physicians and institutions should develop strategies to improve the informed consent process in the best interests of patients.
Strategies for improving the consent process in emergency settings
The process of obtaining consent has been described as the most fundamental element in building a successful physician–patient relationship . As Bernat and Peterson have reported, “all surgeons should conceptualize consent not as a discrete event but as an ongoing bidirectional process of communication, education, question-answering, and listening with the patient or surrogate that proceeds through the continuum of care” . In shared decision-making, the physician serves as the patient’s partner. Physicians provide patients with their professional knowledge about diagnosis, treatment options, prognosis, and possible risks and benefits, and frequently propose treatment recommendations. Patients may provide physicians with information about their own values, life goals, and treatment preferences to help physicians recommend a proper approach [63,64,65].
Informed consent should be regarded as a continuing conversation and discussion between patient and physician throughout the patient’s care [13, 25, 63, 66, 67]. Patients may change their minds about treatment decisions at any time in response to changes in their condition and to additional information they may receive. Thus, “informed consent is also viewed as a process of patient-centered decision-making” .
Schwarze et al. proposed a best-case/worst-case framework for physicians communicating with patients and families during medical decision-making . Physicians may provide an overall picture for patients and families about all potential choices, what the best-case and the worst-case scenarios may be, and where the patient may lie on the continuum. The framework provides a feasible tool for physicians to align patients’ comorbidities, values, and preferences, and to help patients make treatment decisions. We believe that this framework may also be applied to trauma patients.
Improving patient comprehension
Many strategies have been adopted to achieve better patient understanding, including use of illustrative materials, leaflets and pamphlets, video descriptions, interactive computer programs [69,70,71,72,73,74,75,76,77,78], and “repeat back to me” or testing with feedback strategies [79,80,81]. Such strategies have both advantages and limitations. In our research, written information was reported to be helpful for trauma patients [41, 44]. However, such material usually requires active collaboration and compliance on the part of the patient, and transfer of knowledge concerning procedures and risks to the patient is often limited. Some studies indicate that a significant number of patients do not even read the consent form before signing , while one study concluded that trauma patients often need repeated verbal explanations of procedures and potential complications rather than written information alone .
Using video or multimedia modalities to educate patients and assist informed consent seems to produce satisfactory results. Several studies have shown that using a video-assisted method to educate patients resulted in better patient satisfaction and improved patient knowledge of procedures and risks [74, 77, 83, 84]. Some studies also found that the use of educational videos can reduce physician counseling time [75, 85]. Two of the included studies had introduced the use of videos for trauma patient education, with promising results [40, 46].
Because most of these studies focused on elective procedures or surgeries, and because the problem of patient understanding and information retention may be greater with trauma procedures and surgeries, institutions should develop effective educational tools to foster the informed consent process. Delivering such information is fundamental, as is the provision of supportive materials . Therefore, it is crucial to standardize the communication process for patients and their families to improve the effectiveness and efficiency of the communication process. Using the information aids mentioned above could reduce the burden of communication between physicians and patients, and could improve the consent process by delivering standardized information .
“Most patients have a positive attitude toward receiving information” . However, at what level necessary information becomes “sufficient” is an important determinant of patient satisfaction; more attention should be focused on this area . Nnabugwu et al. reported that efforts should be made to ensure that consent information, including the nature of the disease condition, the nature of planned procedures, and risks, are satisfying from the patient’s viewpoint . Some studies recommended that it was crucial to use the scientific method to define the core information for informed consent [90, 91] and to involve patients in the development process .
One included study used a mobile smartphone  and one used a laptop computer to deliver information . The weight and size of modern electronic tools have previously limited their application in emergency settings. However, recent advances in portable and tablet computer technology provide good opportunities for improving patient education for surgery . Innovative, less bulky portable computers have larger screen displays, larger memory storage, and good image resolution, and can more easily deliver educational information and high-quality videos. The use of such innovative computer technology may help with preoperative education in trauma patients requiring emergency surgery. Such technological tools, however, should never replace interaction between the physician and the patient, and patients should be given an opportunity to ask questions and voice their concerns.
Obtaining adequate informed consent in the emergency department is a challenging and time-consuming process. Because of the involuntary nature of emergency care, informed consent is the only way to respect patients’ autonomy. Providers must communicate complicated medical information to patients to help them make informed decisions. In most emergency settings, the time constraints and stress as well as patient distress caused by pain or other acute symptoms result in patients and their families having difficulty understanding the significant information needed to provide valid informed consent. Hence, the use of video to assist the informed consent process for surgery may offer a practical solution. The use of video to support preoperative education may improve both patient satisfaction and comprehension.
The importance of effective and efficient preoperative education and communication as well as the entire consent process before emergency surgery should not be underestimated. A good consent process will dramatically increase the satisfaction of trauma patients undergoing emergency surgery. To obtain informed consent effectively and efficiently, a comprehensive tool and a standardized consent process should be developed in emergency settings for trauma patients and their families.
Implications for future research
Informed consent is very important in trauma patients but has rarely been studied in this population. Further studies are needed on the details of the informed consent process in trauma patients, including the determinants affecting the process and the satisfaction of trauma patients. Further research is needed to confirm the effectiveness of different information-delivery methods in trauma patients, to facilitate development of the most effective strategy for the process.
Furthermore, further exploration is needed on providing adequate education and training to healthcare providers so that they can deliver structured and comprehensive information to trauma patients in a timely manner, establishing a good patient–physician relationship and building trust.
Moreover, informed consent might be waived for patients who are in medical emergencies. Further research is needed to explore how many unconscious trauma patients undergo emergency surgery without informed consent or surrogate consent, and how healthcare providers define such medical emergencies. More research is needed about the relationship between patient outcomes and their decision-making process.
Implications for policy and practice
This review revealed that research on informed consent for trauma patients, including the best tools to convey complete information on possible risks and treatments, is rare. This lack of research might greatly limit patients’ ability to obtain sufficient information concerning risks and benefits, information that would enable them to make autonomous decisions that respect their values and really benefit them. We recommend that appropriate information aids should be provided so that healthcare providers do not provide only verbal information with imprecise terms to describe risks and outcomes (such as low, uncommon, etc.). Patients provided with such imprecise information might overestimate or underestimate the possible harm.
Computerized and interactive programs can provide patients with tailor-made, individualized information to help them comprehend all necessary information in a very short time frame. We believe that information aids have many advantages for trauma patients. The model of shared decision-making is currently favored, especially when there are two or more options for treating one condition, each with different risks and benefits, with no single best treatment, and in which professional consensus is not yet achieved. For instance, the options for treating splenic laceration include surgical treatment (splenectomy or splenorrhaphy) and nonsurgical treatment (conservative or transarterial embolization). Each option has its own risks and benefits. In some circumstances, healthcare providers must discuss these options with patients before making treatment decisions.
Our study has several strengths. The search strategy was comprehensive. As far as we know, no other review study has focused on this topic. Our review also has several limitations. The searched articles are rare, and meta-analysis and quantitative analysis were not possible because of the heterogeneity of the data. Because the articles are rare and thus the study sample is relatively small, publication bias is possible. The results reveal a positive effect, but negative effects are possible in unpublished studies.