Surgical Informed Consent Process Research Articles

Surgical Informed Consent in Clinical Practice: Patients' Perspective Undergoing Cesarean Section at Three Teaching Hospitals in Addis Ababa, Ethiopia.

Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the diagnosis and the treatment so that they can make informed decisions. This study was to assess the practice of surgical informed consent in Addis Ababa. An institution-based cross-sectional study was undertaken in Addis Ababa in 2021. A total of 312 women who underwent cesarean section were interviewed immediately after their hospital discharge. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeons' standards of informed consent practices for surgical procedures. Almost all (100 %) of the respondents were asked to provide written consent, and 96.2 % of them signed the consent form. Most women (89.4%) received information about the indication(s). Few (18.6%) respondents were informed about the type of anesthesia to be administered while only 9 %( n= 28) of them were given an opportunity to choose the option of anesthesia. Only 44.9% of the respondents have received at least six of the 13 components of SIC suggested by the investigators. In this, the most secured data was the signature of the patient which is 96 %. The least documented element of SIC was alternative treatment. A majority of women who underwent both elective and emergency cesarean section did not receive comprehensive information during the Surgical Informed Consent process in the study hospitals. There is a need that patients need to be counseled during antenatal visits, specifically when patients visit near term for antenatal checkups.

Patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia

BackgroundInformed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020.MethodsA facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face interviews were conducted using structured questionnaires. A systematic sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant.ResultsTotally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction.ConclusionPatient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients' needs and obey a standard informed consent to improve patient satisfaction.

Informed Consent Prior to Elective Gynaecological Surgery in Two Reference Hospitals in Yaound&amp;#233;, Cameroon: A Mixed Methods Study

Introduction: Informed consent is a process that enshrines respect for patients’ autonomy, their dignity, and their rights to determine what happens to their own bodies. We set out to describe the surgical informed consent process and evaluate its quality in patients undergoing elective gynaecological surgeries in two University Teaching Hospitals in Yaounde, Cameroon. Methods: This was a cross-sectional, prospective study over 9 month period, from October 1st, 2018, to June 30th, 2019 at the Yaounde Gynaeco-Obstetric and Paediatric Hospital (YGOPH) and the Yaounde Central Hospital (YCH). By administering a modified Brezis questionnaire 48 hours after surgery, we obtained data which enabled us to evaluate and score the informed consent process and obtained written reports of patients’ appreciation of key aspects of the informed consent process prior to surgery. We then called each participant 6 months after their surgery date to obtain information on the occurrence or not of post-operative complications. Results: We recruited 72 patients aged 24 to 68 years old (61 at YGOPH, 11 at YCH). The operating gynaecologist sought patient consent in 65.3% (49/72) of cases, while 61.1% (44/72) of the subjects would have loved to have more information on surgical risks; 69.4% (50/72) were satisfied with the consent process; and 56.9% (41/72) could recall and repeat the information they received prior to surgery. While 37.5% (27/72) had poor quality (non-valid consent), 40.3% had good quality consent (valid). Consent administered by the gynaecologist (OR = 0.172; 95% CI = 0.060 - 0.049) was a strong determinant of valid consent. Also, patients with non-valid consent significantly reported more complications (OR = 4.469; 95% CI = 1.412 - 14.147) than those with valid consent. Conclusion: Informed consent prior to elective gynaecological surgeries in our study was poor. The timing of the consent process, as well as the person involved in the process affect the validity of the consent.

Improving Surgical Informed Consent: Unanswered Questions.

This study reviews randomized clinical trials that have attempted to improve the process of informed consent. Consent should be guided by the ethical imperatives of autonomy, beneficence, and social justice. Informed consent is constantly evolving. Yet our review of the randomized trials done to improve the surgical informed consent process raises a number of questions: How does one define surgical informed consent? What interventions have been tried to measure and improve informed consent? Have the interventions in informed consent actually led to improvements? What efforts have been made to improve informed consent? And what steps can be taken to improve the process further? A literature search for randomized controlled trials (RCTs)on informed consent identified 70 trials. Demographics, interventions, assessments, and a semi-quantitative summary of the findings were tabulated. The assessments done in the RCTs, show the surrogate for patient autonomy was comprehension; for beneficence, satisfaction and mental state (anxiety or depression); and, for social justice, language, literacy, learning needs, and cost. There were 4 basic categories of interventions: printed matter; non-interactive audiovisual tools; interactive multimedia; and a smaller group defying easy description. Improvement was documented in 46 of the 65 trials that studied comprehension. Thirteen of 33 trials showed improved satisfaction. Three of 30 studies showed an increase in anxiety. Few studies tried to assess primary language or literacy, and none looked at learning needs or cost. No single study improved all 3 principles of informed consent. Validated interventions and assessments were associated with greater impact on outcomes. All 3 ethical principles should be assessed; autonomy (as comprehension), beneficence (as satisfaction, anxiety), and social justice. Not enough consideration has been given to social justice; appropriate language translation, standardized reading levels, assessment of learning needs, and cost to the individual are all important elements worthy of future study.

How SURPAS May Improve the Surgical Informed Consent Process

Journal of the American College of Surgeons 230(6):p 1033-1034, June 2020. | DOI: 10.1016/j.jamcollsurg.2020.04.008

Use of Surgical Risk Preoperative Assessment System (SURPAS) and Patient Satisfaction During Informed Consent for Surgery

The objective of this study was to determine the effects of using the Surgical Risk Preoperative Assessment System (SURPAS) on patient satisfaction and surgeon efficiency in the surgical informed consent process, as compared to surgeons' "usual" consent process. Patient perception of the consent process was assessed via survey in 2 cohorts: 10 surgeons in different specialties used their "usual" consent process for 10 patients; these surgeons were then taught to use SURPAS, and they used it during the informed consent process of 10 additional patients. The data were compared using Fisher's exact test and the Cochran-Mantel-Haenszel test. One hundred patients underwent the "usual" consent process (USUAL), and 93 underwent SURPAS-guided consent (SURPAS). Eighty-two percent of SURPAS were "very satisfied" and 18% were "satisfied" with risk discussion vs 16% and 72% of USUAL, respectively. Of those who used SURPAS, 75.3% reported the risk discussion made them "more comfortable" with surgery vs 19% of USUAL, and 90.3% of SURPAS users reported "somewhat" or "greatly decreased" anxiety vs 20% of USUAL. All p values were <0.0001. Among SURPAS patients, 97.9% reported "enough time spent discussing risks" vs 72.0% of USUAL patients. The SURPAS tool improved the informed consent process for patients compared with the "usual" consent process, in terms of patient satisfaction, ie making patients feel more comfortable and less anxious about their impending operations. Providers should consider integrating the SURPAS tool into their preoperative consent process.

Insight in Information Provision Prior to Obtaining Surgical Informed Consent-by Audiotaping Outpatient Consultations.

Literature suggests that patient-informing process prior to obtaining surgical informed consent (SIC) does not function well. This study aimed to provide insight into the current practice of SIC in the Netherlands. This is a prospective, observational, and multicenter study, conducted in one academic and two non-academic teaching hospitals in the Netherlands. Audio recordings were made during outpatient consultations with patients presenting with Dupuytren Disease. The recorded informing process was scored according to a checklist. Written documentation of the SIC process in the patient's chart was compared to these scored checklists. Time spent on SIC during the consultations was also recorded. A total of 41 outpatient consultations were included in the study. Consultations were conducted by 25 plastic surgeons and their residents. Average time spent on SIC was 55.6% of the total consultation time. Considerable variation was observed concerning the amount and type of information given and discussed. In 59% of the consultations, discrepancies were observed between written documentation of consultations and audio recordings. Information on treatment risks, the postoperative period, and the operating surgeon was addressed the least. Despite a relatively large part of the consultation time being spent on SIC, patients received scarce information concerning treatment risks, postoperative period, and who their operating surgeon would be. Discrepancies were observed between the written documentation of SIC and information recorded on the audio recordings. This occurred predominantly in one hospital that used a pre-made list of 'discussed information' in its digital patient chart.

A decade of litigation regarding surgical informed consent in the Netherlands

ObjectiveAn inadequate surgical informed consent process (SIC) may result in a medical malpractice claim or medical disciplinary board (MDB) complaint. Aim of this study was to analyse characteristics of a decade of malpractice claims and MDB decisions regarding SIC in the Netherlands. MethodsA retrospective analysis of malpractice claims and MDB decisions concerning SIC disputes in four major surgical specialties was conducted based on company data from the largest medical malpractice insurance company and two public available online MDB databases. ResultsA total of 11376 malpractice claims and 661 MDB complaints were filed between 2004–2013 and 676(6%) of these claims and 69(10%) of these complaints involved an alleged deficient SIC process. A random sample of 245(37%) claims and all MDB decisions were analysed. Reasons for filing a claim or complaint were insufficient counselling or recording of SIC elements. In 20% of lawsuits and 25% of claims the case resulted in favour of the complainant. ConclusionA substantial portion of malpractice claims and MDB decisions is related to a deficient SIC process. Practice implicationsFocusing on crucial SIC elements for patients may improve satisfaction and expectations and result in a lower risk for malpractice claims and MDB complaints.

The Question of Whether Orthopaedic Surgeons Should Delegate Informed Consent to PAs and NPs

PAs and NPs in orthopaedic surgery assist surgeons with a variety of medical tasks, including obtaining informed consent. However, a recent Pennsylvania Supreme Court decision may have far-reaching implications for future practice by possibly narrowing the scope of physician extenders in the surgical informed consent process.

Surgical Informed Consent Process in Neurosurgery.

The doctrine of informed consent, as opposed to medical paternalism, is intended to facilitate patient autonomy by allowing patient participation in the medical decision-making process. However, regrettably, the surgical informed consent (SIC) process is invariably underestimated and reduced to a documentary procedure to protect physicians from legal liability. Moreover, residents are rarely trained in the clinical and communicative skills required for the SIC process. Accordingly, to increase professional awareness of the SIC process, a brief history and introduction to the current elements of SIC, the obstacles to patient autonomy and SIC, benefits and drawbacks of SIC, planning of an optimal SIC process, and its application to cases of an unruptured intracranial aneurysm are all presented. Optimal informed consent process can provide patients with a good comprehension of their disease and treatment, augmented autonomy, a strong therapeutic alliance with their doctors, and psychological defenses for coping with stressful surgical circumstances.

Exploring the Patient Decision-Making Process in Choosing Route of Hysterectomy [5E

INTRODUCTION: Laparoscopic hysterectomy offers clear benefits to patients when compared to abdominal (open) hysterectomy, yet a large percentage of women continue to undergo the latter procedure. The purpose of this study is to explore the patient decision-making process in choosing the route of hysterectomy. METHODS: A questionnaire survey was mailed to all patients (N=3,878) who underwent hysterectomy at a suburban community hospital between 2011-2013. Questions addressed preoperative education, patient involvement, and patient satisfaction. Quantitative data was summarized in contingency tables and analyzed using Pearson chi-square; qualitative data was analyzed using content analysis. RESULTS: The overall response rate was 10.3%. Nearly a third of respondents underwent open hysterectomy. Of those respondents, 48.2% indicated the route of hysterectomy “didn’t matter” to them and 13.7% “didn’t know about other surgical options,” compared to 14.8% and 8.5%, respectively of the laparoscopic group. Of the open group, nearly one third (31.7%) indicated their surgeon “did not talk about alternatives to open hysterectomy.” Compared to the laparoscopic group, open respondents were less likely to seek a second opinion, opting to have the surgery performed by their OB/GYN (44%), because “they trusted their OB/GYN” (76.6%). Only 1% of the open group performed on-line research regarding their surgical options. Of the open group, only 76% said they would recommend the same route of surgery, compared to 90.32% of the laparoscopic group. CONCLUSION: The outcomes of this study point to a need for improved preoperative patient education and patient involvement in the surgical informed consent process.

Surgical informed consent in children: a systematic review

BackgroundThe purpose of the article was to analyze current literature on surgeon and parents’ understanding and role in the informed consent process for children undergoing surgery. MethodsA systematic database search (MEDLINE, EMBASE, PsycINFO, and EBM Reviews) was performed to identify articles concerning any aspect of the surgical informed consent for children undergoing an invasive procedure. Articles analyzing informed consent in research studies, non–English-language articles, review articles, case reports and/or series, letters–commentaries, and dentistry and/or nursing-related articles were excluded. Articles meeting inclusion criteria were analyzed to identify common themes related to the process of informed consent. ResultsOne hundred seventy-eight articles were identified on primary search, after removing duplicates and screening titles for relevance, 83 abstracts were reviewed. Thirty-two additional abstracts were identified by secondary search. Twelve of 115 articles met inclusion criteria. Analysis identified five different study themes. Information delivered during consent (Content) was studied in five articles (42%), three (25%) studied the mechanics or delivery of the information (Delivery), three (25%) studied parent participation and discussion (Interchange), six articles (50%) discussed surgeons' perceptions or the parents’ ability to understand or recall the information (Comprehension), and five articles (42%) evaluated surgeon or parent satisfaction or anxiety (Satisfaction). None of the articles studied all five categories. ConclusionsStudies of the surgical informed consent process in children are scarce. Prospective studies evaluating surgeon and parent perception regarding the Content, Delivery, and Interchange of information as well as Comprehension and Satisfaction are needed to understand barriers to the surgeon–patient relationship and to optimize the informed consent process in children undergoing surgery.

Checklist to improve informed consent process in pediatric surgery: A pilot study

PurposeThe purpose of this study was to develop and validate a checklist to standardize surgical informed consent process. MethodsA checklist was created following a literature search. Consent processes were observed from general surgery (GS) and urology (US) in the pre- and post-intervention phases. Competent patients/guardians were asked to complete a satisfaction questionnaire. All trainees and staff surgeons were interviewed on the checklist's utility. Results73 observations (GS=39, US=34) and 66 observations (GS=30, US=36) were made in the pre- and post-intervention phase, respectively. Our checklist increased the frequency with which surgeons explained alternative treatments (pre-intervention 23.3% vs. post-intervention 81.8%), the role of trainees (15.1% vs. 72.7%), and the potential outcomes of not pursuing surgery (60.3% vs. 87.9%). The patient/guardian average satisfaction score increased between phases within GS (mean[standard deviation] 3.55[0.58] vs. 3.85[0.24]); p=0.002), but not within US (3.53[0.61] vs. 3.52[0.54]); p=0.705) or the overall sample (3.54[0.59] vs. 3.67[0.46]); p=0.329). Interestingly, there was no significant improvement in patient/guardian average anxiety levels in GS (X2=0.069, p=0.793), US (X2=0, p=1) or the overall sample (X2=0.143, p=0.706) following the intervention. ConclusionOur checklist aids in standardizing the informed consent process. However, it did not significantly change satisfaction or anxiety levels of patients and guardians. Type of studyPrognosis study. Level of evidenceLevel III.

Challenging the knowledge base and skillset for providing surgical consent by orthopedic and plastic surgeons in the Netherlands: an identified area of improvement in patient safety.

BackgroundSuccessfully completing a surgical informed consent process is an important element of the preoperative consult. A previous study of Dutch general surgeons demonstrated that the implementation of SIC did not meet acceptable standards. However, the quality of the SIC process in the orthopedic surgical or plastic surgical arena is unknown.MethodsFollowing ethical approval, an online survey investigating specifics of surgical informed consent was performed among members of the Dutch Scientific Association of Orthopedic Surgeons and the Dutch Society for Plastic Surgery.ResultsA total of 335 responses from a majority of departments of orthopedic (86 %) and plastic surgery (78 %) were eligible for analysis. Scores on knowledge were poor as only 50 % recognized the three basic elements of surgical informed consent (competence, exchange of information and consent). The orthopedic group used more tools in the surgical informed consent process, such as instruction movies and websites or specialized nursing staff, compared to plastic surgery (orthopedic: 31-50 % vs. plastic: 6-30 %, p = 0.05- < 0.001). In contrast, surgical informed consent forms were used more frequently by the plastic surgical group (orthopedic 21 % vs. plastic:42 % p < 0.001). Control of the efficacy of the surgical informed consent process was low, 36 % in both groups. One in every seven orthopedic or plastic surgeons was faced with an official surgical informed consent-related complaint in the previous five years.ConclusionsSimilar to general surgeons, Dutch orthopedic and plastic surgeons demonstrate poor knowledge and skills regarding surgical informed consent. Increased awareness, better training and use of modern tools including standard forms and online software programs will improve the SIC process and will optimize patient care.Electronic supplementary materialThe online version of this article (doi:10.1186/s13037-016-0110-0) contains supplementary material, which is available to authorized users.

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?

IntroductionLiving kidney donors comprise a unique group of “patients”, undergoing an operation for the benefit of others. The informed consent process is therefore valued differently. Although this is a team effort, the surgeon is responsible for performing the donor nephrectomy, and often the one held accountable, should adverse events occur. Although there is some consensus on how the informed consent procedure should be arranged, practices vary. The aim of this study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosure of complications. MethodsA web-based survey was sent to all kidney transplant surgeons (n = 50) in eight transplant centers with questions regarding the local procedure and disclosure of specific details. ResultsResponse rate was 98% (n = 49), of which 32 (65%) were involved in living donor education; overall, transplant- (50%), vascular- (31%), and abdominal surgeons (13%), and urologists (6%) performed donor nephrectomies in the eight centers. Informed consent procedures varied, ranging from assumed to signed consent. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 13 (41%), three surgeons (9%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied. ConclusionImportant complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended.

Outcomes and risk factors of cardiac arrest after vascular surgery procedures

Despite increased awareness of the value of discussing patients' goals of care, advance directives, and code status as part of the surgical informed consent process, the actual outcomes and risks of cardiopulmonary resuscitation (CPR) remain poorly defined among some subsets of surgical patients. Thus, in an effort to generate an evidence base for communication about shared decision making and informed consent for vascular surgery patients and their surrogates, we defined the incidence, risks, and outcomes of postoperative cardiac arrest after primary vascular surgery procedures. The 2007 to 2010 National Surgical Quality Improvement Program data were queried to develop a multi-institutional database of patients undergoing vascular surgery (N = 123,581). Univariate analyses and multivariate logistic regression were used to identify crude and adjusted risk factors for postoperative cardiac arrest requiring CPR and to assess outcomes. Postoperative cardiac arrest requiring CPR was seen in 1234 of 123,581 patients (1.0%) after vascular surgery at a mean of 7.2 ± 2 days. The 30-day mortality was 73.4% compared with 2.7% among patients who did not arrest (P < .001). Of CPR survivors, 102 (12.1%) were still hospitalized at 30 days. Patient variables that were most predictive of postoperative cardiac arrest included dependent functional status (odds ratio [OR], 2.9; 95% confidence interval [CI], 2.3-3.6; P < .001), dialysis dependence (OR, 2.7; 95% CI, 2.3-3.2; P < .001), emergent case (OR, 2.2; 95% CI, 1.9-2.5; P < .001), and preoperative ventilator dependence (OR, 2.0; 95% CI, 1.5-2.7; P < .001). Procedures associated with the highest risk included thoracic aortic surgery (OR, 6.9; 95% CI, 4.8-9.9; P < .001), open abdominal procedures (OR, 3.7; 95% CI, 3.1-4.4; P < .001), axillary-femoral bypass (OR, 2.1; 95% CI, 1.3-3.2; P = .001), and peripheral embolectomy (OR, 1.5; 95% CI, 1.2-1.9; P = .002). At least one major complication preceded cardiac arrest in 47.7% of patients including sepsis (23.5%), renal failure (14.5%), and myocardial infarction (12.1%). Patients with do not resuscitate orders were significantly less likely to undergo CPR (OR, 0.59; 95% CI, 0.39-0.93; P = .021). Patients undergoing vascular surgery who suffer a postoperative cardiac arrest frequently die in spite of receiving CPR; for those who survive, there is likely to be prolonged hospitalization and significant morbidity. These data provide an evidence base for discussing goals of care, advance directives, and code status with vascular surgery patients and their surrogates. Further research into how to best communicate risk, to elicit patient preferences, and to engage in shared decision making is needed.

A survey of the current practice of the informed consent process in general surgery in the Netherlands

BackgroundA properly conducted surgical informed consent process (SIC) allows patients to authorize an invasive procedure with full comprehension of relevant information including involved risks. Current practice of SIC may differ from the ideal situation. The aim of this study is to evaluate whether SIC practiced by Dutch general surgeons and residents is adequate with involvement of all required elements.MethodsAll members of the Dutch Society of Surgery received an online multiple choice questionnaire evaluating various aspects of SIC.ResultsA total of 453 questionnaires obtained from surgeons and residents representing >95% of all Dutch hospitals were eligible for analysis (response rate 30%). Knowledge on SIC was limited as only 55% was familiar with all three basic elements (‘assessment of preconditions’, ‘provision of information’ and ‘stage of consent’). Residents performance was inferior compared to surgeons regarding most aspects of daily practice of SIC. One in 6 surgeons (17%) had faced a SIC-related complaint in the previous five years possibly illustrating suboptimal SIC implementation in daily surgical practice.ConclusionsThe quality of the current SIC process is far from optimal in the Netherlands. Surgical residents require training aimed at improving awareness and skills. The SIC process is ideally supported using modern tools including web-based interactive programs. Improvement of the SIC process may enhance patient satisfaction and may possibly reduce the number of complaints.

Patients' Perceptions and Expectations of Family Participation in the Informed Consent Process of Elective Surgery in Taiwan

This study investigated patients' perceptions and expectations of their families' participation in the informed consent process of elective surgery. This is a survey study. Anonymous questionnaires that were mailed to potential participants included a demographic data sheet and a scale, measuring patients' perceptions of themselves and their families' participation level in the informed consent process. A convenience sample of patients who had undergone surgery and had been discharged within 4 months from a medical center in southern Taiwan (n=1,737) were recruited. One hundred and forty-five recipients replied, gaining a response rate of 10.0%, and 120 provided complete data. The mean age of the participants was 56.0 years (range 20-85, SD=14.98), and more than half were female (54.2%). Twenty-one participants (17.5%) perceived having less family participation than their own participation in the surgery informed consent process, and 40% expected more family participation in the process. The mean scores of the self-rated participation level was significantly higher than that of the families (p < .001). Patients' expectations of family participation were significantly higher than their perceptions of family participation (p < .001). Eleven patients (9.2%) reported having more family participation than they expected. Participants received the most information about the disease during the informed consent process and the least information about alternatives to surgery. Age, gender, number of previous surgeries and admissions influenced the study participants' perceived level of participation in the informed consent process. This preliminary study demonstrates that patients' perceptions and expectations for family participation in the surgical informed consent process vary. Healthcare providers should be aware of patients' expectation to appropriately invite their family into the informed consent process.

Effect of the Informed Consent Process on Anxiety and Comprehension of Patients Undergoing Esophageal and Gastrointestinal Surgery

ObjectiveThis study seeks to evaluate the level of anxiety, recall, and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery. MethodsSixty-one patients without cognitive disorders entered a prospective study designed to assess the effect of a surgical informed consent process. The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation. The State Trait Anxiety Inventory test was used to assess state anxiety and tract anxiety. The test was repeated after the informed consent process. A disease-specific feedback questionnaire was subsequently administered to assess the actual comprehension of the provided information. ResultsA significant decrease of the state anxiety scores was documented in most patients (p < 0.001). This effect was more evident in the elderly (p = 0.021) and in those who used Internet as a previous source of information (p = 0.032). The mean correct exact answer rate on the disease-specific questionnaire was 76% (IQ range 66.7–85%). No statistically significant relationship was found between the rate of correct answers and the state anxiety scores. ConclusionsAn exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are candidates to minimally invasive esophageal and gastrointestinal surgical procedures.

A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

BackgroundInformed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process.MethodsRelevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed.ResultsThe body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose.ConclusionsIC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.