Risks of COVID-19 for surgical cancer patients: The importance of the informed consent process.
Ontology highlight
ABSTRACT:
SUBMITTER: Wainstein AJA
PROVIDER: S-EPMC7323393 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description: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.
| S-EPMC5544373 | biostudies-other
Project description:BackgroundProper informed consent is essential for patients to have sound knowledge about the indication, risks, and benefits of a proposed surgical procedure. The study aim was to assess the perceptions of postoperative patients about the informed consent process and identify various influential factors in a tertiary care hospital.MethodsA cross-sectional study was conducted from February to August 2018 at a tertiary care hospital in Lahore, Pakistan. A validated questionnaire was used to conduct interviews of 101 patients planning to undergo elective surgery after fulfilling all ethical considerations. A purposive sampling technique was employed to enroll and the data analysis was performed by using SPSS version 23.ResultsOut of total 101 patients, 50 (49.5%) of them were males and the mean age of total sample was 36.98 ± 14.23 years. The majority 92 (91.1%) considered informed consent to be important and that it did not influence their surgical decision 85 (84.2%). Consent was obtained by the consulting surgeon from 41 (40.6%) patients and by the residents/house officer from 60 (59.4%) patients. Fifteen (14.8%) patients signed the consent form themselves, and 86 (85.1%) relatives of patients signed. Ninety-eight (97.0) patients were told about indications of the surgery, and 54 (53.5%) were told about possible complications. Seventy-five (74.3%) patients were informed about alternatives to surgery. Significant reasons for not signing were language (p = 0.03), educational status (p = 0.002), and not being informed by relatives before signing (p = 0.02).ConclusionThe patients had adequate knowledge about the process of informed consent and considered it important. Factors identified as barriers to signing the consent form by the patients themselves included language, better educational status, and not being asked by relatives. It is imperative to involve the patients in the process of consent, especially in signing by them or in their presence by their surrogate.
| S-EPMC8767235 | biostudies-literature
Project description:Background and aimsDuring the COVID-19 pandemic, surgical practice may deviate with operative and non-operative management considered. Appropriate discussion of options with patients is paramount to quality surgical care. Intercollegiate and EAES guidelines recommend discussing and documenting risk of COVID-19 exposure in the consent process for patients undergoing surgery.Materials and methodsClosed-loop audit of consent forms for patients undergoing emergency and elective surgical procedures. Interventions implemented included education of wider surgical teams. Data was collected during a one-week period for each cycle and analysed using Chi-squared test.ResultsIn cycle 1, 6/17 (35.3%) case notes documented discussion of COVID-19 risk. Following intervention, compliance improved to 23/29 (79.3%) cases in cycle 2 and 33/45 (73.3%) cases in cycle 3.ConclusionPre-intervention, our consenting practice was non-compliant. Our interventions led to significant and sustained improvements in practice. We recommend provision of wider surgical team education to facilitate good consenting practice.
| S-EPMC7544629 | biostudies-literature
Project description:BackgroundInformed consent is one of the safeguarding of the patient in medical practice at different standards such as ethical, legal, and administrative purposes. Patient knowledge and perception of informed consent are one of the priority concerns in surgical procedures. Patient knowledge and perception towards informed consent increased patient satisfaction, feeling high power on their determination, and accountability for the management, and facilitated positive treatment outcomes. Despite this, in Ethiopia, there are small-scale primary studies with inconsistent and inconclusive findings. Therefore, this systematic review and meta-analysis study estimated the pooled prevalence of patient knowledge and perception of informed consent and its determinants in Ethiopia.MethodsWe searched major databases such as PubMed, Hinary, MEDLINE, Cochrane Library, EMBASE, Scopus, African Journal Online (AJO), Semantic Scholar, Google Scholar, google, and reference lists. Besides this, University databases in the country were also searched from August 20, 2023, until September 30, 2023,. All published and unpublished studies that report the prevalence of patient knowledge and perception toward informed consent and its associated factors were included. All studies reported in English were included. Studies conducted between January 01, 2015 to September 30, 2023 were included. There are three outcome measurements pooled level of patient knowledge towards informed consent, pooled level of patient perception towards informed consent, and pooled effect that affects patient knowledge of informed consent. Three reviewers (MMM, NK, and YT) independently screened the articles that fulfilled the inclusion criteria to avoid the risk of bias. The studies' quality was appraised using a modified Newcastle-Ottawa Scale (NOS) version.ResultsThe pooled prevalence of appropriate patient knowledge and perception towards informed consent was 32% (95% CI: 21, 43) and 40% (95% CI: 16, 65) respectively. Having formal education 2.69 (95% CI: 1.18, 6.15) and having a history of signed informed consent before 3.65 (95% CI:1.02,13.11) had a statistically significant association with good patient knowledge towards informed consent.ConclusionThe appropriate patient knowledge and perception of informed consent in Ethiopia is low. Formal education and history of signed informed consent were positive factors for appropriate patient knowledge of informed consent in Ethiopia. Physicians, policymakers, and health facility managers should focus on patients without prior experience with signed informed consent and not have formal education to improve patient knowledge towards informed consent. The protocol was registered at Prospero with number CRD42023445409 and is available from: https://www.crd.york.ac.uk/PROSPERO/#myprospero .
| S-EPMC10787976 | biostudies-literature
Project description:Informed consent is a foundational ethical and legal principle in human subjects research and clinical care. Yet, there is extensive debate over how much information must be disclosed to meet ethical goals and legal requirements, especially about non-medical risks. In this online, survey-based experiment of a diverse sample of the US general population, we explored one aspect of this debate by testing whether the level of detail included in informed consent regarding genetic anti-discrimination protections alters individuals' willingness to participate in a hypothetical research study and their concerns regarding genetic discrimination. Participants were randomized to receive sample informed consent language with one of three levels of disclosure regarding the protections and limitations of the Genetic Information Nondiscrimination Act (GINA). Our sample (n = 1,195) had a mean age of 45.9 (SD = 17.9) years and 40% with ≤high school education. Participants were 51.3% female and 36.7% non-Hispanic White. On average, those who received consent language with none of GINA's limitations highlighted were more willing to participate than those who were warned about various gaps in GINA. They also had significantly lower perceived risk of discrimination than those presented with the most information about limitations. Our study found that providing more comprehensive information about GINA notably lessened willingness to participate in the hypothetical studies, highlighting the need for clinicians and researchers to thoughtfully consider how to disclose anti-discrimination risks in informed consent.
| S-EPMC9722586 | biostudies-literature
Project description:BackgroundInformed consent (IC) is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions.MethodsAdult postsurgical patients in nine general hospitals of Italy's Campania Region were interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire.ResultsThe written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients (age???60) and patients with higher levels of education were more likely to read the written IC form.ConclusionsThe written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients' needs. To improve the quality of communication we suggest enhancing physicians' communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures.
| S-EPMC6323683 | biostudies-literature
Project description:BackgroundLittle is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding.ObjectiveTo describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information.DesignDescriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal).ParticipantsTwo hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives.MeasurementsNumber of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36).ResultsParticipants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension.ConclusionsLower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.
| S-EPMC1831581 | biostudies-literature
Project description:BackgroundThere is no consensus on which risks to communicate to a prospective surgical patient during informed consent or how. Complicating the process, patient preferences may diverge from clinical assumptions and are often not considered for discussion. Such discrepancies can lead to confusion and resentment, raising the potential for legal action. To overcome these issues, we propose a visual consent tool that incorporates patient preferences and communicates personalized risks to patients using data visualization. We used this platform to identify key effective visual elements to communicate personalized surgical risks.ObjectiveOur main focus is to understand how to best communicate personalized risks using data visualization. To contextualize patient responses to the main question, we examine how patients perceive risks before surgery (research question 1), how suitably the visual consent tool is able to present personalized surgical risks (research question 2), how well our visualizations convey those personalized surgical risks (research question 3), and how the visual consent tool could improve the informed consent process and how it can be used (research question 4).MethodsWe designed a visual consent tool to meet the objectives of our study. To calculate and list personalized surgical risks, we used the American College of Surgeons risk calculator. We created multiple visualization mock-ups using visual elements previously determined to be well-received for risk communication. Semistructured interviews were conducted with patients after surgery, and each of the mock-ups was presented and evaluated independently and in the context of our visual consent tool design. The interviews were transcribed, and thematic analysis was performed to identify major themes. We also applied a quantitative approach to the analysis to assess the prevalence of different perceptions of the visualizations presented in our tool.ResultsIn total, 20 patients were interviewed, with a median age of 59 (range 29-87) years. Thematic analysis revealed factors that influenced the perception of risk (the surgical procedure, the cognitive capacity of the patient, and the timing of consent; research question 1); factors that influenced the perceived value of risk visualizations (preference for rare event communication, preference for risk visualization, and usefulness of comparison with the average; research question 3); and perceived usefulness and use cases of the visual consent tool (research questions 2 and 4). Most importantly, we found that patients preferred the visual consent tool to current text-based documents and had no unified preferences for risk visualization. Furthermore, our findings suggest that patient concerns were not often represented in existing risk calculators.ConclusionsWe identified key elements that influence effective visual risk communication in the perioperative setting and pointed out the limitations of the existing calculators in addressing patient concerns. Patient preference is highly variable and should influence choices regarding risk presentation and visualization.
| S-EPMC9107059 | biostudies-literature
Project description:Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability) or is illiterate, it has be obtained from a legally acceptable representative (LAR). If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/her signatures to the consent form. For children < 7 years, verbal consent is essential and for mature minors (age group 7 to 18 years) informed assent should be obtained.
| S-EPMC5527718 | biostudies-other
Project description:BackgroundInformed consent is a process that needs time and effort to satisfy patients' desires. Patient dissatisfaction on preoperative informed consent process may be caused by multiple factors of clinical practice. This study aimed to assess patients' satisfaction and associated factors of informed consent process among elective surgical patients.MethodsA cross-sectional study was conducted on 404 postoperative patients who signed the informed consent for elective surgery. A systematic sampling technique was applied to select the study participants. Modified Leiden perioperative patient satisfaction tool was adapted to assess patients' satisfaction with preoperative informed consent process. Data were entered in to Epi-data version 4.20 and exported to SPSS version 20 for analysis. Bivariate and multivariable logistic regression was computed to identify independent variables associated with patient satisfaction towards preoperative informed consent process. A p-value of less than 0.05 was used to declare the statistical significance.ResultsThe overall satisfaction of patients with preoperative informed consent process was 70.3%. Multivariable logistic regression analysis revealed that, being male (AOR: 4.75, 95% CI: 2.47-9.16), primary school (AOR: 8.42, 95% CI: 4.74-7.55), secondary school (AOR: 2.17, 95% CI: 5.74-8.62), rural residence (AOR: 1.8, 95% CI: 2.1-3.9) and received general anesthesia (AOR: 2.92, 95% CI: 1.62-5.26) were significantly associated with patients' satisfaction with the informed consent process.ConclusionThe overall patients' satisfaction on preoperative informed consent process was relatively low. Being male, low level of education, living in rural area, and receiving general anesthesia were significantly associated with patients' satisfaction on informed consent process. Surgeons and anesthesia professionals need to work more to improving the satisfaction of patients with preoperative informed consent process. Researchers are expected to do periodic assessment of patients' level of satisfaction and factors affecting satisfaction.
| S-EPMC9289491 | biostudies-literature