Application of 3D printing technology for pre-operative evaluation, education and informed consent in pediatric retroperitoneal tumors
Joong Kee Youn, Sang Joon Park, Young-Hun Choi, Ji-Won Han, Dayoung Ko, Jeik Byun, Hee-Beom Yang, Hyun-Young Kim
Scientific Reports, 30 January 2023
Open Access
Abstract
To investigate usefulness of 3D printing for preoperative evaluations, student and resident education, and communication with parents or guardians of patients with pediatric retroperitoneal tumors. Ten patients planning retroperitoneal tumor resection between March and November 2019 were included. Preoperative computed tomography (CT) images were used for 3D reconstruction and printing. Surveyed items were understanding of preoperative lesions with 3 different modules (CT, 3D reconstruction, and 3D printing) by students, residents, and specialists; satisfaction of specialists; and comprehension by guardians after preoperative explanations with each module. The median age at operation was 4.2 years (range, 1.8–18.1), and 8 patients were diagnosed with neuroblastoma. The 3D printing was the most understandable module for all groups (for students, residents, and specialists, P = 0.002, 0.027, 0.013, respectively). No significant intraoperative adverse events or immediate postoperative complications occurred. All specialists stated that 3D printing enhanced their understanding of cases. Guardians answered that 3D printing were the easiest to comprehend among the 3 modules (P = 0.007). Use of 3D printing in treatment of pediatric patients with retroperitoneal tumors was useful for preoperative planning, education, and parental explaining with obtaining informed consent.
Effects of a video-based positive side-effect information framing: An online experiment
Effects of a video-based positive side-effect information framing: An online experiment
Friederike L. Bender, Winfried Rief, Joscha Brück, Marcel Wilhelm
Health Psychology, 2023
Abstract
Objective
Despite the public health value of vaccines, vaccination uptake rates are stagnating. Expected adverse events following immunization are a major source of concern and play a role in the emergence of vaccine hesitancy. Since nocebo mechanisms are involved in the perception of adverse reactions, positive side-effect communication is warranted. The aim of the present study was to compile a comprehensive communication strategy that minimizes expectations of nocebo effects while respecting the informed consent procedure.
Method
In a randomized 2 × 2 between-subject design, 652 participants received information about COVID-19 or influenza vaccination using either standard side-effect messaging or messaging enriched with proven elements of expectation-optimizing framing. A physician presented information online via video. Moderation analyses were conducted to examine effects among particular subpopulations. Expected adverse event ratings following an imagined immunization, cost-benefit ratios of the vaccination, and future vaccination intentions were assessed.
Results
Information content ratings were equally high in each group. Positive framing significantly decreased adverse event expectations in the COVID-19 information group and raised the cost-benefit ratio in the influenza condition, indicating higher benefits than cost expectations. Moderation analysis revealed that the framed side-effect communication lowered the expected COVID-19 vaccination uptake willingness in individuals with strong anti-vaccination attitudes.
Conclusions
Facing the ongoing coronavirus mass vaccinations, positive information frames have a small but significant impact on vaccination concerns while upholding informed consent. Although intervention trials are still pending, this approach could help decrease vaccine hesitancy by reducing fearful expectations. However, it seems that it should not be used without considering vaccination attitudes.
Individualised consent for endoscopy: update on the 2016 BSG guidelines
Individualised consent for endoscopy: update on the 2016 BSG guidelines
Guideline
Nicholas Ewin Burr, Ian D Penman, Helen Griffiths, Andrew Axon, Simon M Everett
Frontline Gastroenterology, 7 February 2023
Abstract
In 2016, the British Society of Gastroenterology (BSG) published comprehensive guidelines for obtaining consent for endoscopic procedures. In November 2020, the General Medical Council (GMC) introduced updated guidelines on shared decision making and consent. These guidelines followed the Montgomery ruling in 2015, which changed the legal doctrine determining what information should be given to a patient before a medical intervention. The GMC guidance and Montgomery ruling expand on the role of shared decision making between the clinician and patient, explicitly highlighting the importance of understanding the values of the patient. In November 2021, the BSG President’s Bulletin highlighted the 2020 GMC guidance and the need to incorporate patient -related factors into decision making. Here, we make formal recommendations in support of this communication, and update the 2016 BSG endoscopy consent guidelines. The BSG guideline refers to the Montgomery legislation, but this document expands on the findings and gives proposals for how to incorporate it into the consent process. The document is to accompany, not replace the recent GMC and BSG guidelines. The recommendations are made in the understanding that there is not a single solution to the consent process, but that medical practitioners and services must work together to ensure that the principles and recommendations laid out below are deliverable at a local level. The 2020 GMC and 2016 BSG guidance had patient representatives involved throughout the process. Further patient involvement was not sought here as this update is to give practical advice on how to incorporate these guidelines into clinical practice and the consent process. This document should be read by endoscopists and referrers from primary and secondary care.
Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Research
Evelien De Sutter, Pascal Borry, Isabelle Huys, Liese Barbier
BMC Health Services Research, 21 February 2023; 23(181)
Open Access
Abstract
Background
Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research.
Methods
Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis.
Results
Stakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard.
Conclusion
The creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level.
[Improper informed consent of the patient: legal and expert assessment]
[Improper informed consent of the patient: legal and expert assessment]
Kratenko MV
Sudebno-meditsinskaia Ekspertiza, 1 January 2023; 66(1) pp 59-62
Abstract
The purpose of the study is to draw the attention of the legal and medical community to the problem of insufficient awareness of the patient about the upcoming medical intervention; to identify the scope of interaction between the court and the expert in relation to disputes related to improper information. Despite the fact that the conclusion about improper informing of the patient implies a legal assessment of the circumstances, special medical knowledge is needed to identify some defects of voluntary informed consent. The expert, in particular, can answer the questions of the court about what risks are characteristic of a certain type of medical intervention (perforations, bleeding, etc.) and how high their probability was in relation to a particular patient (taking into account his state of health, anatomical features); whether there were alternative treatment options. Based on the explanations received, the court will be able to assess whether the patient’s attention was focused on the relevant circumstances, whether his consent was conscious, and the complications that occurred were foreseeable.
Editor’s note: This is a Russian language publication.
Principles of Informed Consent for Perinatal and Neonatal Nurses
Principles of Informed Consent for Perinatal and Neonatal Nurses
Rebecca L. Cypher
The Journal of Perinatal & Neonatal Nursing, January-March 2023; 37(1) pp 10-13
Excerpt
An informed consent process includes a patient’s ability to make a decision, a conversation explaining pertinent information to make a choice, and an agreement to receive a definitive type of care. Malpractice disputes are sometimes centered on whether a patient received adequate consent from a clinician prior to a treatment or procedure. In fact, The Joint Commission reported 49 informed consent–related sentinel events over an 11-year period. Consent arguments may arise in perinatal and neonatal allegations when an action results in an adverse event. As an illustration, a family claims that an infant’s death from a subgaleal hemorrhage was caused by an operative vaginal birth. These allegations stem from an accusation that informed consent incorporating maternal and newborn risks was not attained beforehand.
Obtaining informed consent goes beyond a signature on a form. Consent for care is vital for communication and shared decision-making between a clinician (eg, physician or advanced practice nurse) and a patient, a newborn’s parent, or a guardian. This process is designed to provide precise measures that allow patients to have an opportunity to ask questions and make an informed decision. From a liability perspective, when individuals fully comprehend risks and benefits of a treatment, they may cope better with a less than optimal outcome resulting from any care provided. In some circumstances, patients may be less likely to file a malpractice claim. This column offers a primer addressing certain doctrines of informed consent in a perinatal or neonatal setting…
Informed Consent in Dental Practice: A Qualitative Analysis of Awareness and Apprehensions Among Practitioners in South India
Informed Consent in Dental Practice: A Qualitative Analysis of Awareness and Apprehensions Among Practitioners in South India
Dr Baiju R M, Dr Elbe Peter, Dr Vivek Narayan, Dr Roshna E K, Dr Abhilash Babu, Dr Nandimath Omprakash V
International Journal of Social Science And Human Research, 2 February 2023; 6(2)
Open Access
Abstract
Context
The push for autonomy and liberalization has transformed the practice of medicine and dentistry from paternalism to a patient cantered model. Patient’s choice to accept or reject the proposed treatment is central to this new paradigm of health care. Informed consent is an essential tool for an ethical dental practice.
Aim
The objective of the present study was to explore the knowledge, attitudes, perceptions and prevailing practices among dentists regarding the informed consent process.
Materials and methods
A phenomenological approach was undertaken. A semi structured telephonic interview was conducted based on a flexible topic guide and continued until data saturation.
Statistical analysis
The data was transcribed verbatim. Coding and categorisation done. Anonymity was ensured in all steps. The data was subjected to a thematic analysis.
Results
Participants were apprehensive about the influence of social media on the new paradigm of doctor patient relationship and the increasing utility of specialists as a protection from litigation. Lack of clarity regarding the consent method has prevented its routine application.
Conclusions
It can be concluded that a comprehensive understanding regarding informed consent process was lacking among the participants.
Iranian women’s experiences of the episiotomy consent process: a qualitative study
Iranian women’s experiences of the episiotomy consent process: a qualitative study
Malihe Ghiasvand, Fatemeh Nahidi, Sedigheh Sedigh Mobarakabadi, Hamid Alavi Majd
British Journal of Midwifery, 1 February 2023; 31(2)
Abstract
Background
Knowledge of the benefits and complications of interventions related to medical procedures, such as episiotomy, enables women to make informed decisions regarding these interventions. This study investigated women’s experiences of the episiotomy consent process in Iran.
Methods
This qualitative study gathered data from 20 women through in-depth semi-structured interviews. The participants were selected from hospitals, health centers and gynecology clinics in Tehran. Content analysis was used to establish themes from the gathered data.
Results
The participants’ experiences showed that they felt that their needs were not met and that they were excluded from decision making regarding their birth.
Conclusions
Women were excluded from decision making and their unmet needs presented ethical challenges in the performance of episiotomy procedures. Neglecting women’s expectations, inducing absolute trust in obstetricians or midwives and failing to obtain informed consent paved the way for forced episiotomies. Proper education and obtaining informed and voluntary consent may facilitate women’s rights being respected.
Awareness of Post-Operative Patients Regarding Informed Consent Form in Public Tertiary Care Hospital of Peshawar Khyber Pakhtunkhwa: A Cross Sectional Survey
Awareness of Post-Operative Patients Regarding Informed Consent Form in Public Tertiary Care Hospital of Peshawar Khyber Pakhtunkhwa: A Cross Sectional Survey
Original Article
Bakhtyar Ali Shah, Muhammad Anwar, Nusrat Begum, Naheed Akhtar, Amir Sultan, Muzamil Tariq, Sumaira Bibi
Pakistan Journal Of Health Sciences, 31 January 2023
Open Access
Abstract
The informed consent form is one of the components of bioethics. Written consent from the patient must be obtained prior to any medical or surgical procedure to give the patient freedom of choice. This factor has always been neglected when caring for patients in most third world countries.
Objective
To assess postoperative patient awareness of informed consent at Peshawar KP Tertiary Public Hospital (HMC).
Methods
This study was conducted from April 2021 to August 2021 at Hayatabad Medical Complex, a tertiary care public hospital in Peshawar. A total sample of 70 patients was drawn by consecutive selection. An adopted and pre-tested questionnaire was used for data collection. Questions were filled in by having the patient understand the question and receiving the answer from the patient.
Results
The majority (59%) of the patients included in this study were male, while the mean age was 35 years and the majority of the patients (44%) were illiterate. Awareness of variables (2–7) was 60%, 47%, 30%, 47%, 69%, and 53%, respectively, while awareness levels from questions 8–12 were 59%, 47%, 82%, 40%, and 60%, respectively.
Conclusions
The results of the current study indicate that the perception of informed consent among patients in tertiary care public hospitals is reasonably satisfactory, although some lack of participant knowledge of key issues has been identified and needs to be improved through education and awareness.
Surgical Informed Consent: A Scoping Review of Physician-facing Decision Support Tools
Surgical Informed Consent: A Scoping Review of Physician-facing Decision Support Tools
Review
Alexa D. Melucci, Mariah R. Erlick, Anthony Loria, Marcia M. Russell, Larissa K. Temple, Gabriela C. Poles
Annals of Surgery Open, March 2023; 4(1)
Abstract
Objectives
Physician-facing decision support tools facilitate shared decision-making (SDM) during informed consent, but it is unclear whether they are comprehensive in the domains they measure. In this scoping review, we aimed to (1) identify the physician-facing tools used during SDM; (2) assess the patient-centered domains measured by these tools; (3) determine whether tools are available for older adults and for use in various settings (elective vs. emergent); and (4) characterize domains future tools should measure.
Methods
Using the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews, Embase, Medline, and Web of Science were queried for articles published between January 2000 and September 2022. Articles meeting inclusion criteria underwent title and abstract review. Eligible studies underwent data abstraction by two reviewers.
Results
Of 4365 articles identified, 160 were eligible. Tools to aid in surgical SDM focus on elective procedures (79%) and the outpatient setting (71%). Few tools are designed for older adults (5%) or for nonelective procedures (9%). Risk calculators were most common, followed by risk indices, prognostic nomograms, and communication tools. Of the domains measured, prognosis was more commonly measured (85%), followed by alternatives (28%), patient goals (36%), and expectations (46%). Most tools represented only one domain (prognosis, 33.1%) and only 6.7% represented all four domains.
Conclusions and Implications
Tools to aid in the surgical SDM process measure short-term prognosis more often than patient-centered domains such as long-term prognosis, patient goals, and expectations. Further research should focus on communication tools, the needs of older patients, and use in diverse settings.
Center for Informed Consent Integrity 