Consent while initiating any form of treatment is an integral part of the medical ethics, and before conducting any form of healthcare intervention, the physician is being advised to seek the consent of the patient. Any form of surgery, whether major or minor, may have grave complications, and hence the complications, or any form of potential danger that might occur as an outcome of the surgery must be communicated to the patient. It is only after the patient agrees to undertake the involved risks, does the physician will perform the surgery. At present, various laws in most of the countries have also mandated that the surgeon must communicate and disclose any form of complication associated with the surgery to the patient, and only after her agrees to undertake the risk by assigning the agreement form, should the surgical process initiate. Thus, as it is evident from the above discussion that informed consent in the form of explicit agreement by signature is indispensible before undertaking a surgery. However, it is important to note here that so far all the past research studies had emphasized the importance of obtaining consent from the patients before undertaking a surgery, with a focus on the ethical and legal obligations of the physician towards the patient. The main research gap that has always prevailed here is what are the probable challenges associated with the process of gaining consent from a patient about to undergo surgery (McFadden et al., 2014). Besides, studies suggest that factors such as strong religious influence, language or cultural barriers and or patient perceptions can prove to be potential challenges in the process of gaining the patient consent and proceeding with the treatment (Gilbert& Gillespie, 2017).
Thus, as it is evident from above, keeping in mind the potential challenges and issues of obtaining informed consent from a patient before undertaking surgery, the present research intends to examine the importance as well as the limitations and drawbacks of obtaining surgical consent from the patient, and offer recommendations if any, for the same. The act of obtaining consent is not a simple task, since the patient may be unconscious, unable to give the consent, or he may not fully understand the risks involved and offer the consent. In case of post –surgical complications, the doctor can be blamed. Hence, the present research intends to analyze what are the common challenges the medical experts face while obtaining surgical consent, and how the same can be avoided.
The aim of the present research was to understand the importance of surgical informed consent in context of optimal patient care. The research was carried out to analyze the challenges that are faced by the health care professionals while obtaining the informed consent of patient prior to surgery. The research also considered recommending strategies that when implemented can successfully eliminate the challenges acting as barriers in the way of obtaining surgical consent. .
The present research had the following objectives-
Keeping in mind the nature of the research that is to be conducted for addressing the research question, it was suitable to undertake a systematic literature review for fulfilling all the research objectives. A systematic review is a process of identifying comprehensively most of the studies relevant to the research question focused on the research objectives. This form of studies draws upon the existing literature, summarizes the results, presents the main findings, cite limitations of present knowledge and identify factors for dissimilar results across a wide range of studies. In such a form of review, there is more transparency as compared to narrative reviews (Neuman,, 2016).
Summary of search strategy- A comprehensive search for literature was conducted for the present systematic review. The searches for retrieving appropriate articles were carried out on major biomedical databases. Citations were sought from different specialized journal articles that were peer reviewed, with the use of relevant key words.
Databases used- The electronic databases that were used for the search were CINAHL, Medline, PubMED, EMBASE, Cochrane and Science Direct. These databases provide with a large pool of literature on varied subjects. The articles found in these databases are authentic and reliable as they are peer-reviewed. Recent articles are found in these databases and it is an easy process to extract articles from here. Full-text articles were available in these databases along with abstract of articles.
Search terms/ Keywords used- Search terms are words or short phrases taken from the research topic and research objectives that are entered for retrieving the relevant information pertaining to the research question. The search terms used for the present literature review were surgical, surgery, consent, surgical consent, informed consent, patient, surgeon, health. Search terms were adapted as per the database that was being used.
Boolean operation- Boolean operations are logical terms used in combination with search terms for making the process of search more effective. Using these terms makes the search more focused by eliminating the inappropriate hits and retrieving the appropriate hits. The results of the search are more productive in such cases. The Boolean operations used for the review were AND and OR.
Selection criteria- Data was selected in a systematic manner. Articles published on year 2006 and thereafter were considered for the study. The articles had to be full-text. From each database, the relevant articles were shortlisted for further screening. 37 studies were considered for the second round of screening after considering the title of the articles. Both qualitative and quantitative studies were considered for the study. For each of the articles shortlisted, the full article were read and appraised for the final selection of the articles. 21 articles were finally included in the present literature review. These articles had content on surgical consent, its importance, challenges faced in obtaining informed consent and recommendations to resolve the conflicting issues. All studies were in English language while articles from different countries were taken for providing a generalized conclusion from the study.
Data extraction- For the studies that had primary research, the participants were about to undergo surgery or had already undergone and faced the situation of providing consent. Studies considered both cases were the patients had provided consent as well as a surrogate had provided the consent. Qualitative articles were appraised using the Consolidated criteria for reporting qualitative research (COREQ) checklist while the quantitative articles were appraised using the PRISMA checklist.
Data analysis-The main findings of the articles were analyzed and reported in the present review. Comparison and contrast between the findings of the articles were put forward in the discussion section to highlight the gaps in literature and implications for future practice.
Before a surgery is being done, the surgical consent plays an important role in it, as it is the sole instrument of communication between the doctor and the patient with an expression of authorization and permission regarding the next step to be taken. It is the ethical as well as the legal obligation of the healthcare expert to offer a set of comprehensive information to the patient and his family regarding any kind of risk, side effect or surgical alternatives that is available. However, despite its undeniable necessity, the implementation of the informed consent process is indeed a tough one. It has been observed that often the patients do not understand the complications that can occur in the post-surgical period, and their lack of knowledge regarding the nature of the surgery compels them to sign the agreement form without realizing the risks, side effects or benefits of the same. However, recent research reports suggest that most of the healthcare experts solely emphasize the importance of obtaining signature of the patient, and less attention is being provided to ensure the complete understanding of the surgical procedure on part of the patient (Robb et al., 2014). However, shortage of time, lack of facilities to communicate with the patient or even unwillingness of the healthcare experts result in the patients signing the agreement for, without fully comprehending the risks, benefits or side effects. There are four basic elements involved in a surgical consent procedure, namely- risks, benefits, side effects and alternatives that must be communicated to the patient. Yet it is indeed a shocking fact that all the four factors were being explained on the consent form only 26.4% of the time. However, since surgical consent plays an important role before a surgery is being conducted, it is important to discuss and critically analyze the problems involved in gaining consent from the patient. While at times, the patient’s health condition prevents the doctors from gaining consent from him, in other situations, the lack of health literacy on part of the patient or his family compels him to provide consent, without realizing the gravity of the situation (Prochazka et al., 2014). However, in any case, once these patients develop nay form of post-surgical complications, they start laming the healthcare organization or expert only. The act of obtaining surgical consent from the patient remains central to the health and well-being of the patient, and hence it is important to understand how the consent can be obtained from the patient, by communicating to him all the factors involved.
It is important to note that there are multiple challenges associated with the act of gaining consent from the patient. For example, often the patient himself is anesthetized, or he is unconscious, and a surgery has to be done immediately, in such a situation, the expert will have to conduct the surgery in an unconsented way. For example, a patient before her surgery was found to have consented to a total vaginal hysterectomy only, and yet since her ovary also had a fallopian tube, adhered to the uterus it had to be removed only, without the consent of the patient. In case of such unanticipated events or medical emergencies, a doctor may have to select a different surgical procedure than what was consented, however the ethical obligations of carrying a surgery like this way can be questioned (Friedrich et al., 2014).
It has been noted that initially the consent before performing a surgery was being taken by a doctor, who thought himself incapable of performing the surgery successfully. However, in later times, surgical consent became an important issue also because the consent has been deemed as a way of protecting the doctor from any sort of unwanted touch. Besides, it is also the duty of the doctor to ensure that the patient is well-informed regarding possible side effects and probable risks associated with the surgery to be performed (John et al., 2016). It has often been observed that a surgery involves various complications in the post-surgery period, and hence it is advisable that the patient is being well-informed about the probable consequences.
However, recent research reports have pointed out that despite the undeniable importance of surgical consent, the process of gaining the consent successfully from the patient involves many challenges. For example, the legal requirements of the surgical consent clearly state that the patient who would be undergoing the surgery should be informed about the risks and conditions of the surgery, and only s/he is entitled to give the consent to the doctor. However, in many countries including the states of the US, it has been observed that people of various cultures need their families to give the consent instead of the concerned patient (Grady, 2015). Consequently, even if the patient needs to be aware of the risk and conditions of the surgery, his family members are the persons to give the consent on behalf of him. However, the ethical obligation of the healthcare expert lies in his responsibility to convey the information to the patient and obtain the consent from him only (John et al., 2015).
Again, it has been observed that people often travel to other countries where they sign the surgical consent form without understanding the language or the medical jargons fully. As a result, they still remain unaware while signing the agreement form. The problem here is that in every situation, especially during the emergency cases, it is not always possible for the doctors to sit down and explain every aspect of the agreement form in a simplified way. Thus, though the patients initially sign and give away the consent, in later staged when complications arise, they often accuse the doctor or the healthcare center itself (Nijhawan et al., 2013).
Some critics such as Faden and Beauchamp have also pointed out that while performing surgeries and obtaining consent from the patients, the doctors usually emphasize the importance of obtaining the consent through a written agreement (Miyata et al., 2014). However, in most of the cases, a layman fails to decipher or read through the complex words and medical jargons of the written agreement, and hence it is important to disclose and explain the written conditions in a simplified way. In absence of effective communication, the doctors may fail to help the patients understand the probable risks involved, and this may create problems in future. Besides, it is equally important to state here that the empirical evidence has also suggested that there is a huge variation in the type and nature of the information disclosed. In most of the cases, the medical experts are not trained enough to communicate the risks involved in performing surgery. AS a result, either the written agreement end up in scaring the patient, as he anticipates exaggerated consequences, or he undermines the potentiality of the risks involved, and give away easy consent. In most of the cases, the patients possess meager information about the surgical treatment or the alternatives available for the same (Stain, 2016).
Hallock et al., (2017) researched about patient satisfaction and informed consent for surgery. As per the authors, informed consent is the process requiring time s well as efforts. The underpinning principles is that informing the patient about the surgery enables the health care professional to promote patient satisfaction and consider them for the decision making process in their treatment course. The objective of the study was to explore the limit to which preoperative satisfaction with a decision of pursuing surgery establishes a relationship with understanding after a discussion held regarding informed consent. An observational study with adult women was undertaken who sought surgical treatment for pelvic floor disorder. The informed consent process included a discussion of the benefits, indications, alternatives, risks, and chance of success of the procedures. A 35 question survey was filled by the participants preoperatively. Satisfaction with decision was the primary outcome that was measured with the help of a validated 6 item Satisfaction with Decision Scale-Pelvic Floor Disorder. The primary exposure was patient knowledge of the planned surgery and was measured using a newly adapted 20 item Informed Consent Questionnaire including 15 yes/no questions and 5 free-text questions. A total number of 150 women took part in the study. The results indicated that there were no significant differences between the not satisfied group and the highly satisfied group with respect to education level, race, age, health literacy and anxiety level. The relationship between knowledge and decisional satisfaction was persistence after controlling for clinical and demographic variables including health literacy, race/ethnicity, age, and education level. The study indicated that patient understanding of the surgery and related complications and knowledge about the key aspects of the surgery and chances of optimal health outcomes were pivotal components for the patient satisfaction level. The decisions taken by the patients, regarding providing consent to the surgery was highly dependent on such patient education factors. Health care professionals are to face challenges while getting surgical consent from patients if patient education is not adequate. If healthcare professionals consider measuring the understanding level of the patients after informed consent discussions, they would be better able to manage preoperative expectations, thereby improving levels of patient satisfaction and eventually informed consent.
Anderson and Wearne (2007) undertook a study to find the best practice for informed consent for elective surgery. Increasing litigation and the urge to provide patients with information regarding their own treatment have been discusses in light of the concerns related to informed consent and the best practices for obtaining it. For a patient to take up a sensible decision regarding his own treatment, they are to be provided with appropriate information. The principles of the research that the authors undertook were applicable for any elective surgical procedure. Routine elective surgery is a standardised procedure, and the potential risks of surgery are known to all. Despite this fact, the risks mentioned by healthcare professionals at the time of informed consent would differ as a combination of personal experience, personal practice, and variable training. As per the needs of the patients, the degree of variation might be changed. The researchers argue that patients should be asked for their informed consent at the time of listing for surgery. They further advocate that junior medical staff must undergo adequate training for obtaining informed consent. This can be desirably performed by a senior staff. There is a need to inform the patients about the risk of complications posing a substantial amount of risk for undesirable consequences. Challenges come up in due course of receiving informed consent if the patient is not competent to take up his own decisions or if the patient has not received sufficient information for making the appropriate decision. There may be issues arising if the consent if taken on the last day before the surgery. The majority of the patients take the decision of proceeding with the surgery long before the consent is signed. However, a smaller section of the patient population might be facing doubts and might be in dilemmas. It is, therefore, a wise thought to receive the informed consent well before the time of surgery, thereby providing the patient with adequate time to avoid dilemmas. One drawback of the article was that there was no emphasis on the signing of the consent form. Though the signing of consent form marks the completion of the consent process, it is not to be considered as part of the acquisition of the informed consent.
Cainzos and Gonza´lez-Vinagre (2014) discussed about informed consent in surgery in their research paper. The researchers conducted a literature review of the existing literature on the concerned topic and outlined the significant components of informed consent in surgery to be physician disclosure, patient understanding and patient decision making. As per the authors, informed consent is a highly vital factor in any form of surgery in the contemporary healthcare system. It is not just about granting the authorisation for starting with the surgery. Informed consent is a complex process, and the most compound and complicated part is the transmission of correct information to the patient. Proper channelling of the information to the patient is a necessity against the need of enabling a decision making process free from any challenges and inhibition. Such decisions are mostly in alignment with the values and interests of the patient and are therefore desirable. However, a dichotomy might arise between the outcomes being valued by the surgeons and the patients. A range of tools is to be implemented by the health care settings for the adequate flow of information from the care professionals to the patients. Surgical associations and governments must take up initiatives for developing high quality, suitable and evidence-based standardised information channelling systems that would help the patients. It is to be remembered that the ultimate aim of informed consent is to gain the trust of the patient that benefits both the parties- patient and the care provider. Experts agree that if informed consent for surgery is taken in a correct manner, it gives high patient satisfaction and a sense of safety and security, thereby making the patient show more commitment towards the treatment being provided.
Hanson and Pitt (2016) highlighted the risks and documentation of informed consent prior to surgery. As opined by the authors, informed consent is now being considered as a critical component of surgical practice. The intention of the paper was to discuss any pertaining challenges while adhering to modern standards of receiving informed consent. A common result of surgery is anxiety in patients, and some patients have the possibility of undergoing more amount of stress in comparison to other, which is difficult for carers to handle. Patients are often frightened upon hearing the possible complications of the surgery. All surgeons must strive to reduce this fear and set up an environment to avoid anxiety and its adverse ill effects causing disturbances in the process of administering anaesthesia. The reassuring and calm demeanour is successful in relieving the stress levels. Family members play a key role in here to help the patients reduce their stress levels. Care providers are to encourage family members to provide emotional support and encouragement apart from doing so themselves. Another challenge that comes up in due course of receiving informed consent is language barrier when the family member is responsible for translating the explanation provided by the surgeon. This is due to the fact that the family member might be translating the explanation into brief sentences as a result of which the patients might be getting only a fraction of the information. In such cases, a hospital interpreter might aid in proper communication of the information.
The practice of getting informed consent gains the meaning it holds from biomedical research and medical procedures. Discussions of justified nondisclosure and disclosure have been playing a major role throughout the history of ethics in the medical field. The term ‘informed consent’ is known to emerge in the last six decades. Serious discussion of the ethics and meaning of informed consent have been going around for the past two decades, much due to the evolving demands of healthcare practices (Beauchamp, 2011). As per the authors, multi-faceted challenges emerge when a professional attempts to procure informed consent from patients. The first issue is the limits of the law in ethics. The first challenge is to have a proper understanding of the way the law shapes the understanding of informed consent. Informed consent is a doctrine that is based on legal aspects, and it is often being treated synonymous with the legal doctrine that revolves around liability for injury and disclosure. In classic cases of informed consent, the reigning theory of liability is negligence. This approach is uninformative and misleading to a large extent. Negligence might be a proper basis for understanding the issues pertaining to a case. However, this is an inadequate framework for the purpose of indicating what is to b done in soliciting consent and waiving consent in health care settings. In this regard, it is also to be stated that legal standards are not helpful in being assistance to formulate a conception of informed consent. The standards distract us from a reliable model rather than contributing towards one, partly due to the fact their focus is on illegal treatment and not unethical treatment. The second challenge that the researchers highlight is the quality of consent. Issues about the adequacy and quality of consent are difficult to resolve until refocus of conventional disclosure is achieved. This approach draws concentration of policymakers on the necessity of making policies for successful communication along with indisputable indulgent by patients and subjects. The third challenge derives from present-day apprehensions regarding broad consent. This certain challenge can never be met solely by internal protections while consent is being taken. The authors conclude that providing solution for one challenge might open the path for solutions for other challenges.
Burkle et al., (2013) studied patient perspectives on informed consent for surgery and anaesthesia. The background of the study was that principles of informed consent are legal, morally and ethically grounded in the responsibilities of the physicians towards the patients they provide services to. The study aimed at examining patient’s expectations in relation to informed consent at the time of the perioperative process, particularly the exchange of risk information and time and method of information delivery. The role of patient anxiety and understanding of patient was also to be discussed. Five hundred participants were surveyed with the help of a written questionnaire. The levels of agreement between the patients with informed consent, as well as their preferences for risk discussions were assessed. The impact of the ability of the patients to comprehend care complexities after surgery, anxiety concerns, and presentation methods, were considered for assessment. Most of the patients had the belief that the care providers must discuss with them less consequential and severe yet rare complications of surgery (90% of the population). A small section of the population opined that anxiety cropping up from a discussion about risk factors significantly outweighed the benefits (21% of the population). A smaller section of the population opined that risks are to be discussed while restricting it to appropriate limits on the basis of the inability of the patient to come in terms of complexities of surgery (6% of the population). Patients preferred discussion to be held on the day of surgery or one week before the surgery. Patients had a clear preference for discussion with the providers of anaesthesia alone (44% of the population). 52% of the population preferred discussion to be conducted in combination with a piece of written information provided to them. Only 4% of the population wanted only written information. It was, therefore, concluded from the study that greater awareness of the health care professionals about patient preferences would result in the advanced exchange of information between patients and anaesthesia providers.
The opportunity to learn and perfect surgical skills is a vital element of all surgical training procedure. Trainee surgeons can be allowed to operate on patients, but for achieving the maximal quality of patient outcomes, it is necessary to take consent of the patients prior to the surgery. Informed consent is to be taken for all procedures being undertaken by junior surgeons and patients are to be provided with accurate and clear information about treatment risks. Heath care settings have consent forms stating that they do not take the guarantee about who carries out the operation; however, the professional would be competent enough to carry out the process. Studies have indicated that it is reassuring for patients to understand the need for junior doctors to carry out surgical procedures since this would make their training impactful. Interestingly, a minority of the patients feel that there is no need of junior surgeons to carry out operations during their training. The level of reluctance showed by patients to permit supervised trainees indicates that there are high chances of operative procedures to be diluted in the course of time. What is clear is that patients have a high level of expectancy regarding the surgeon given consent to be explicit regarding the role they play in the overall surgery process. This is likely to impose challenges for professionals for maintaining a balance between their roles as trainee surgeons and their responsibility of giving optimal care to the patients (Ritchie & Reynard 2009).
Goldworth (2010) suggested changes in the informed consent process. Informed consent was initially brought into practice with the purpose of protection of physicians against any probable legal liability. However, at present world, informed consent is not to be viewed as a perfect instrument as suggested by a large pool of literature. For example, it is not an effective tool for addressing the issues of coercion or manipulation is a formal manner that is suitable for physicians to practice. Improvements are therefore warranted that would change the implied meaning of informed consent. At least one method can be applied for changing the process of informed consent that has the least dependence on the introduction of regulations. This way is to make changes in the process so that the patient can express their wishes to the full extent regarding medical options. When a patient visits a healthcare setting for medical help, he is attempting to eliminate the disability and discomfort being faced. Since the patient suffers from a low level of psychological and social well-being, a balance between satisfying the patient’s interests and moderating others is to be maintained. Since the professionals need the patient to be engaged in the consent process for initiating the medical treatment, they have the obligation to see that the process is an accurate representation of the self-governing and independent wishes of the patient. The forms used for consent purpose needs to have a third option where a patient can authorise someone else to take the decisions on his behalf.
Jahaan et al., (2014) argued that multiple factors affect the process of getting informed consent for surgery. The study undertaken was based in Pakistan. Efforts have been made to create ethical guidelines for medical practices, including patient consent. The researchers undertook the study to explore the perceptions of the patients and the factors influencing the process of getting consent to surgery among families of the patients and the patients in a tertiary care setting. Random sampling was done to select 400 patients after they underwent surgery. The participants answered a structured questionnaire. 58.3% of the patients had themselves signed the surgery consent, and 41.7% had their relatives signing it. A proper comparison was done regarding the perceptions of the patients signing the consent forms themselves and the perceptions of the relatives. 63.8% of the patients who had signed the consent themselves stated that they perceived obtaining consent as necessary, while 48.2% of the relatives who signed the consent stated that they perceived obtaining consent as necessary. A majority of the patients, as well as the relatives, agreed that there is a medico-legal implication of getting consent and they demanded detailed consent. Logistic regression analysis of the data collected gave rise to a number of factors that were associated with reluctance to sign the consent form. These included medical terminology, language barrier, culture/ traditions, insufficient time and educational status. The study, however, had some limitations to it. The study was a quantitative one, and a qualitative study would have better expressed the perceptions of the patients. Nevertheless, the study was successful is bringing into the limelight some of the crucial aspects regarding informed surgical consent. The implications for further research was that health care providers need to be sure of the factors underpinning a proper consent obtaining process in order to facilitate the same in practice. Language barrier was identified as the greatest barrier and keeping this in mind healthcare settings must provide translators to better manage the process and make it easier for the patients to provide consent. Items in consent forms, such as terminology, should be taken special care of in order to avoid any potential complication faced by the patients.
Bernat et al., (2006) contributed to the rich pool of literature present on patient centred informed consent in the surgical process. The objective of the study was to review the legal, ethical and medical basis of the principle of informed consent and the complications possible to arise. Such complications arise mainly when there is am incapable patient relying on a surrogate decision maker. Patients want a suitable environment that has provision for discussing the elasticity of the consent being provided. Emphasis on the significance of clear communication and the need for shared decision proves to be a strong foundation for getting consent. The researchers reviewed citation from PubMed for surgical consent, communication between physician and patients, patient-centred medicine, consent guidelines and shared decision making process. Articles were selected that had issues of informed consent for surgery in their discussion. Qualitative aspects of the consent principle were studied. The researchers concluded that surgical consent is not merely a signature on the form. It was argued that surgical consent is an ongoing process that is based on communication and encompasses pre, peri and post-operative care. Consent can be pre-eminently perceived as shared decision making with patients or their surrogates.
Informed consent holds more value than just singing a form. It is a valuable process that provides the patient with a chance to actively take part in the decision making the process for the treatment (Joolaee et al., 2017). Against this backdrop, the researchers assessed the quality of obtaining surgical consent in health care settings affiliated with Tehran University of Medical Sciences. In a descriptive analysis, cross-sectional study, 300 patients were recruited through stratified sampling system. Seven hospitals were considered for the data collection, and these were affiliated to Tehran University of Medical Sciences. Data was collected using a questionnaire that the researchers developed. Data analysis was done with the help of analytical and descriptive statistics using SPSS software. The results of the study were significant. The mean score of quality of acquisition of informed consent was 17.13 out of 35. This indicated that the quality falls in the unsuitable category. The results were an indication that 48% of the signatories were not interested in reading the form before signing it. Among the 52% of the population who read the consent form, 94.2% mentioned the presence of incomprehensible medical, technical, and legal vocabulary, while 61.3% had reported incomprehensibility of the consent form. Only 18% and 12% participants stated that they had no anxiety or fear and they were not in a hurry to sign the form, respectively. Women, those undergoing any special surgery, those with higher levels of education and young patients reported a higher quality of obtaining consent. It was concluded from the study that a poor practice is prevalent in obtaining surgical consent in Iran. It seems necessary to bring about changes in the way surgical consent is taken. From the findings of the study, the researchers suggested that fundamental reforms are needed that would guide informed consent procedure across the globe. It was recommended that people are to become more aware of the rights they have as patients while giving consents. This can be done through different media. Moreover, the factors that hinder the acquisition of consent are to be eliminated by training the professionals. Further studies are warranted that provide more in-depth knowledge on this topic.
Wheeler (2006) pinpointed that there is always scope for undertaking a discussion on surgical consent. As the length of the training of surgeons is gradually diminishing, in spite of the growing interest in the content of surgical curriculum the regulations and the policies governing consent have not received the adequate attention it deserves. The advent of surgical practitioners who have non-medial qualifications has given rise to a number of doubts regarding the limit of knowledge required or ensuring that valid consent is taken. Like all other principles, consent is also vital as the surgical practice is dependent on it and patient care depends on the manner consent is received. The author further pointed out that the traditional approach that is taken for obtaining consent is marked with some negative elements. A physician not in the position of performing the operation required often is found to attempt for obtaining consent. Genuine attempts for protecting patients are to be made in order to reduce the chances of patient anxiety. However, the rare yet grave potential complications are not highlighted adequately. There are some doubts and clarification regarding what is to be disclosed properly, added with the messages delivered by the courts. The consent has been taken from people ineligible for doing so. The authors list down the information that is to be provided while seeking consent. These include the details and purpose of the treatment; options available for treatment; uncertainties and details of the diagnosis; possible short term and long term side effects; explanation of the probabilities of success for all the available options; the details of the physician who are responsible for taking care of the patient; a reminder to the patient that he or she is presented with the option that the decision can be changed later on if convenient.
Grady (2010) had stated that informed consent is an ethical, legal and regulatory requirement that has been well accepted in the multi-faceted health care transactions and health care research. Nevertheless, the practice of getting informed consent tends to show variation from the reality by virtue of different contexts. Nijhawan et al., (2013) states in this connection that informed consent often falls short of linking with theoretical ideals. Developments in recent time clinical research and healthcare call for continuous and remarkable efforts that can successfully address the emerging and enduring challenges that informed consent brings along. Prochazka et al., (2014) however has argued that informed consent has a moral value embedded in it that is not unique in the field of health research or science. Consent has the capability to render moral actions that are morally permitted. A number of interpersonal interactions are integral to informed consent as societal values are well entrenched in it. According to Jahan et al., (2014) surgical consent is the consent obtained from the patient for enhancing shared and collaborative decision making process between the patient and the surgeon or other healthcare professional that aims to reduce errors and enables better patient outcomes. Such consent is taken from the patient for ensuring that there is no negative impact of the surgery in future in terms of moral implications and health implications.
Robb et al., (2014) has opined that informed consent is enveloped by a wide range of challenges that makes the application of informed consent as a critical medical tool debatable. In support of this, Nijhawan et al., (2013) go on to state that the major barriers that arise while receiving informed consent are language barriers, religious influence, false expectations, patient perceptions and level of vulnerability. Hallock et al., (2016) in this regard have opined that ambiguity is a major component of challenges faced by healthcare professionals while obtaining the consent of patients prior to surgery. Confusions regarding the effectiveness of the treatment option that is surgery, often lead to confusions regarding the informed consent as well. It is to be stated in this relation that some surgeries might be too complex and might need many layers of discussion before the final decision is being taken. Explaining the specificities and details of the surgery to the patient is crucial for eliminating any arising confusions. For permitting the patient to have an adequate understanding of the implications of the surgery, it is the duty of the surgeon to provide adequate information in a proper channel. Perceptions of patients are vital while obtaining consent. One aspect might hold one meaning for one person while holding another meaning for another person. It is therefore required to assess the standpoint that patients take regarding any certain criteria of the consent so that there is transparency. This is supported by Wheeler (2006) who believes that there are different proven ways by which the understanding of the patients are to be handled. In this context comes the usefulness of applying concepts of reduced misconceptions, misinterpretations and assumptions. Language and cultural barriers can only be excluded if surgeons consider communicating in a culturally sensitive manner and respecting the values and traditions and customs of the patients. Good patient-surgeon communication is sure to foster good consent (Goldworth, 2010).
Jooaee et al., (2017) outlines the measures by which obtaining surgical consent can be improved in practice for reducing the burden on patients as well as care providers. The most significant of these is the provision of adequate information available to the patient. Ritchie and Reynard (2009) however critiques that adequate information available to the patient is not sufficient to get a proper informed consent in an easy manner and information is to be provided adjunct with emotional support and guidance fostered through an informal relationship. Hanson and Pitt (2011) have to say that patients have a major contribution towards the development of their own preferences and values regarding healthcare goals. Together with their physicians, patients need to consider bringing changes in the values they have developed and their perceptions regarding different healthcare practices, particularly surgery.
Several initiatives can be implemented for improving the way informed consent is obtained from patients and its potential implications for the patients as well as the health care professionals. Firstly, all surgeons must consider the concept of consent as not a discrete event. On the contrary, surgical consent is to be conceptualised as an ongoing bidirectional process of education, question answering, communication and engagement with patient or surrogate through the continuum of care. The surrogate or the patient is to be viewed as a partner working with the surgeon to facilitate a proper decision making process. This can covert the process of informed consent to that of an informed decision making. Understanding the health goals and values of a patient considered for surgery is crucial for providing respectful and appropriate care. Perceiving consent as an ongoing communication with patients helps in compensating for the major pitfalls identified in the process of obtaining consent. These are a lack of adequate time to communicate with the patient and poor timing of the discussion held regarding consent. Ensuring that there is enough space for communication has secondary benefits too, such as reduction of claims of surgical malpractices.
Secondly, a surrogate decision maker must be identified well before the surgery in order to avoid any delay in the surgery. This is to be done in advance when an individual suffers health complications that have chances of leading to surgery. A section of the physicians often shows reluctance to engage in effective communication with the patient regarding advance directives. It is advocated that all patients who are to undergo surgery must be provided encouragement for executing a legal health care directive document identifying an individual who can take up a decision on their behalf. Patients should be encouraged to undertake more than enough discussions with this valuable aspect about their treatment preferences. Third, surgeons must peri-operatively anticipate and discuss complications of the treatment of the patient and eventually learn the preferences of the patient for the option available to them. Spouses and other family members must take part in the discussion so that they also are aware of the preferences of the patients. This step would aid in better outcomes as the patients can be helped to formulate the treatment plan and the family member can represent the wishes of the patient accurately at the time of need.
Finally, surgeons must have an attitude of positivity and hope wherever applicable while communicating with the patient. Hope and faith are necessary for achieving optimal patient outcomes as patients are provided with strength and courage to overcome the stress faced by surgery. An informal relationship between the surgeon and the patient, nurtured by a strong base of communication, trust, mutual understanding is a powerful tool for therapeutic approach. Communication must be culturally sensitive and safe and must respect the ethnic and racial background of the patient. Surgeons must be supportive of the consent provided by the patient and the choices the surrogates make in relation to the patient’s care at different stages (Cabaniss et al., 2017).
Conclusion
From the above literature review, it can be concluded that informed surgical consent holds much value and importance in the field of medical sciences pertaining to optimal care service delivery. Informed consent is the process of obtaining the consent of the patient regarding any medical procedure to be carried out after informing the patient with all relevant information pertaining to the treatment process. This process brings into the picture the competent physician, sufficient information transfer and patient’s consent. In general, the responsibility of obtaining consent is of the physician about to perform the surgery or any of his representatives. Consent is not only a form that is to be filled but a communication process between two parties- the patient and the healthcare professional. Current reports claim that the surgical consent is getting more complex a process day by day, and in fact, it has been observed in one-third of the most complex, problematic and emergency cases, the doctor had to save the life of the patient rather than looking out for the candidate to obtain the consent from. At times, the patient has to undergo a very minor surgery, where the risk of death or any harmful symptom is the least, yet once he is being made aware of the possible risk factors, he might withdraw his decision of undergoing the surgery even if the same is highly recommended in his situation. This can especially occur with patients with low literacy level as they require full knowledge about the probable side effects and risk factors of the surgery, and disclosure of the same might scare him to an extent that it might get difficult for the physician to get him convinced. The challenges faced in obtaining consent encompasses factors like low literacy level, cultural background of the patient, insufficient information transfer and lack of support and encouragement. Granting consent from the patient requires the capacity of the patient to take part in the consent process, in the absence of which a surrogate is helpful. These challenges, though differ in severity from one setting to other, is more or less common for all healthcare settings across the globe.
Countries across the globe have their public health departments putting the focus on the development of policies regarding surgical consent in the light of the rich pool of information generated from research. The purpose of these policies is to ensure that patient’s life is in safe hands and that they are provided with a sound environment that fosters surgical procedures. State, federal and hospital rules regarding permission for surgery and other associated procedures are constantly facing evolution as a result of the changing demands of health care industry. Policy changes are to be made on the basis of continued research highlighting the perspectives of the patient. It only through an understanding of the concerns of the patients, those suitable changes can be brought into practice. Governing bodies must allocate adequate funds and resources for undertaking research on the concerned matter as these researches would improve the way consent is obtained on a daily basis. Evaluation of the policies brought into practice is pivotal to highlight the areas that need further developments and the challenges that the patients, as well as the healthcare providers, continue to face. By undertaking regular monitoring and review the overall process of obtaining surgical consent would be dynamic, marked by some key positive accomplishments.
References
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