Consent Conversations Research Articles

Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial

BackgroundElectronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use.MethodsSWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18–65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively.ResultsParticipants found that group eConsent was an efficient method that it allowed them to hear each other’s questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies.ConclusionGroup eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement.Trial registrationClinicalTrials.gov NCT05471440 (registered on 22nd of July, 2022).

Should Obtaining Informed Consent Be Considered an Entrustable Professional Activity? Insights From Whether and How Attendings Entrust Surgical Trainees.

Because residents are frequently delegated the task of obtaining consent early in their training, the American Association of Medical Colleges describes "obtaining informed consent" as a core entrustable professional activity (EPA) for medical school graduates. However, prior studies demonstrated that residents frequently perform this task without receiving formal instruction or assessment of competency. This study sought to understand how attending physicians decide to delegate obtaining informed consent for surgical procedures to trainees. The authors conducted a survey of attending surgeons at a university-based health care system of 6 affiliated teaching hospitals (October-December 2020) to collect data about current entrustment practices and attendings' knowledge, experience, and attitudes surrounding the informed consent process. Summary statistics and bivariate analyses were applied. Eighty-five attending surgeons participated (response rate, 49.4%) from diverse specialties, practice types, and years in practice. Fifty-eight of 85 (68.2%) stated they "never" granted responsibility for the consent conversation to a trainee, and 74/81 (91.4%) reported they typically repeated their own consent conversation whenever a trainee already obtained consent. The most common reasons they retained responsibility for consent were ethical duty (69/82, 84.1%) and the patient relationship (65/82, 79.3%), while less than half (40/82, 48.8%) described concerns about trainee competency. Reflecting on hypothetical clinical scenarios, increased resident competency did not correspond with increased entrustment ( P = .27-.62). Nearly all respondents (83/85, 97.7%) believed residents should receive formal training; however, only 41/85 (48.2%) felt additional training and assessment of residents might change their current entrustment practices. Attendings view informed consent as an ethical and professional obligation that typically cannot be entrusted to trainees. This practice is discordant with previous literature studying residents' perspectives. Furthermore, resident competency does not play a predominant role in this decision, calling into question whether informed consent can be considered an EPA.

Preoperative investigation practices for elective surgical patients: clinical audit

BackgroundThe findings of pre-operative investigations help to identify risk factors that may affect the course of surgery or post-operative recovery by contributing to informed consent conversations between the surgical team and the patient, as well as guiding surgical and anesthetic planning. Certainly, preoperative tests are valuable when they offer additional information beyond what can be gathered from a patient’s history and physical examination alone. Preoperative testing practices differ significantly among hospitals, and even within the same hospital, clinicians may have varying approaches to requesting tests. This study aimed to investigate preoperative testing practices and compare them with the latest guidelines from the National Institute for Health and Care Excellence (NICE).MethodsThis three-month institutionally based study was carried out at the Debre Tabor Comprehensive Specialized Hospital from May 1 to July 30, 2023, including individuals aged 16 years and older who were not pregnant and had undergone elective surgery in the gynecological, orthopedic, and general units. Data on the sociodemographic characteristics, the existence of comorbidities, the invasiveness of surgery, and the tests taken into consideration by the guideline were gathered using a self-administered questionnaire. After rigorously analyzing and revising the results of preoperative investigation approaches, we compared them to the standard of recommendations. Moreover, the data was analyzed and graphically presented using Microsoft Excel 2013.ResultsDuring the data collection period, 247 elective patients underwent general, orthopedic, and gynecological operations. The majority of patients, 107 (43.32%), were between the ages of 16 and 40 and had an American Society of Anesthesiologists (ASA) class one (92.71%). 350 investigations were requested in total. Of these, 71 (20.28%) tests were ordered without a justified reason or in contravention of NICE recommendations.ConclusionsIn our hospital’s surgical clinical practice, unnecessary preoperative testing is still common, especially when it comes to organ function tests, electrocardiograms (ECGs), and complete blood counts (FBCs). When deciding whether preoperative studies are required, it is critical to consider aspects including a complete patient history, a physical examination, and the invasiveness of the surgery.

Optune (NovoTTF-200A)

What Is the Indication Under Review?
 
 The indication under review is for the treatment of adults with newly diagnosed glioblastoma multiforme (ndGBM) following maximal debulking surgery and completion of radiotherapy together with and after standard of care maintenance chemotherapy. Glioblastoma is the development of cancer among glial cells in the central nervous system and is the most common form of brain cancer in Canada.
 
 What Is Optune?
 
 Optune is a medical device that produces alternating electrical fields called tumour-treating fields to target the growth of cancerous cells in addition to chemotherapy. Current treatment for glioblastoma consists of a combination of surgery, radiotherapy, and chemotherapy.
 
 How Did CADTH Evaluate This Device?
 
 To examine the value of Optune for the treatment of ndGBM, CADTH:
 
 reviewed and critically appraised the clinical and economic evidence submitted by the sponsor
 reviewed the literature to identify and describe ethical considerations relevant to the use of Optune, as well as to assess the validity of the sponsor’s modelling approaches, assumptions, and estimates regarding Optune
 sought input from patient and clinician groups and consulted an expert panel.
 
 
 
 What Did CADTH Find?
 Clinical Evidence
 
 This review included the EF-14 trial, a pivotal, multicentre, open-label randomized controlled trial that assessed the efficacy and safety of Optune plus temozolomide in adults with ndGBM following maximal debulking surgery and completion of radiotherapy, together with and after standard of care maintenance chemotherapy.
 Based on the single trial, there is evidence of low to moderate certainty that Optune plus temozolomide likely increases progression-free survival at 6 months of treatment and overall survival at 24 months of treatment compared to temozolomide alone. The treatment effect of Optune plus temozolomide on progression-free survival and overall survival may be dose-dependent, with at least 18 hours of daily use required for the most benefit.
 Overall, the evidence was of very low to moderate certainty due to concerns regarding selection bias and low generalizability of the results to real-world settings.
 
 Economic Evidence
 
 The submitted fee for Optune is $27,000 per month, which is added to the cost of temozolomide based on its public list price.
 The incremental cost-effectiveness ratio for Optune plus temozolomide versus temozolomide alone was $899,470 per quality-adjusted life-year (QALY) gained (incremental costs = $336,902; incremental QALYs = 0.37).
 Optune plus temozolomide was not considered cost-effective relative to temozolomide alone at conventional willingness-to pay thresholds (i.e., $50,000 per QALY gained and $100,000 per QALY gained). Consequently, a price reduction of between 91% and 97% would be required for Optune plus temozolomide to be considered cost-effective at a willingness-to-pay threshold between $50,000 and $100,000 per QALY gained.
 The budget impact of reimbursing Optune through the federal, provincial, and territorial public drug plans (excluding Quebec) is estimated to be $75,795,323 to cover 232 patients over the initial 3 years of funding.
 
 Ethical Considerations
 
 The extent to which Optune meets patients’ needs for an effective, accessible, and easily usable treatment may depend on an individual patient’s values and caregiver support network, especially as Optune requires managing an additional treatment modality and may require additional caregiver support.
 Further study on how — or if — factors such as functional status, race, sex, age, socioeconomic status, and availability of caregiver support have implications for device uptake and ability to adhere to treatment would be helpful to inform patient-centred and equitable use, given the diverse patient population in Canada.
 Careful attention must be paid to the quality of clinical consent conversations, including considerations of disease progression potentially impairing capacity to consent and requiring a substitute decision-maker.
 Equity-enhancing strategies for implementation will need to be explored to ensure that Optune is accessible in an equitable and effective manner for all eligible patients in Canada.

Ethical and Psychological Considerations for Posthumous-Assisted Reproduction for Adolescents and Young Adults With Poor Cancer Prognosis in the Context of Grief.

Families or loved ones of adolescents and young adults (AYA) with a poor cancer prognosis who preserved fertility and did not survive treatment may choose to pursue posthumous assisted reproduction (PAR; i.e., use of preserved reproductive material for future family-building attempts). Decisions about PAR may be occurring in the context of grief and bereavement, which is associated with ethical and psychological considerations because grief can complicate a person's capacity for informed decision-making. Through the use of a five-step ethical decision-making model, the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct, and a blended case example, the ethical and psychological considerations for families of AYA with poor prognosis who pursue PAR is discussed with an ethical analysis. Ethical and psychological considerations included assessing the potential for harm to involved parties, navigating PAR decision-making with responsibility and honesty, examining the accessibility of PAR, and considering informed consent/assent and autonomy. Clinical recommendations for supporting families and loved ones exploring PAR in the context of grief were discussed, with considerations for improving clinicians' comfort and competence with PAR, incorporating grief into informed consent conversations, standardizing conversations about PAR, and promoting an interdisciplinary approach to PAR-related decisions.

Abstract A086: Increasing the arm of research by finding and training key community stakeholders: The Mayo Clinic "Community Engagement in Research and Clinical Trial (CERCT)" curriculum phase 2

Abstract Background: Equitable representation in research remains a critical issue. Barriers to diversity in research have been identified across personal, provider, and health systems levels. To achieve true health equity, investigators must creatively collaborate with community stakeholders for increased education and partnership. The Mayo Clinic Community Engagement in Research and Clinical Trial (CERCT) curriculum was developed in 2022 to improve the inclusivity and diversity of frontline community-based health workers in research, including community health workers (CHWs), pharmacy technicians, health advocates, and citizen scientists. Aim: The CERCT curriculum was designed to empower and improve the skills necessary for engaging members of the communities about research and clinical trial (CT) participation. Aims for this project include beta pilot training of key community stakeholders in underserved minoritized communities, evaluating the efficacy of CERCT modules through increased recruitment into the Mayo Clinic Florida Community Research Registry; and increased diverse representation in research studies. Methods: This project will train community health advocate cohorts in educating the community on the importance and benefits of participating in research and CT and how to effectively communicate that information within their circles of influence both at work and where they live. Five community health advocate cohorts in Florida counties will be trained through 2-hour online modules, taken at their leisure. Results: Eight online module units will be utilized for beta training of CHWs, pharmacy technicians, health advocates and citizen scientists. Modules include explaining importance of biomedical research and CT; recognizing the different types of research and human participation studies; describing the importance/need of increased representation and inclusion; identifying how the safety, welfare, and well-being of participants are protected at every step in the research process; understanding the role of healthcare providers in research participation; learning communication strategies and tools to raise awareness of CT; examining at an in-depth level the informed consent process and conversation with potential participants; and learning to build trust and address common patient concerns and questions. Efficacy will be assessed via community enrollment in the Mayo Clinic Community Research Registry. Conclusion: Currently, community health workers and pharmacy technicians are an underexplored avenue for disseminating CT education and research inclusivity. The development and beta testing of a curricula specifically created for key community stakeholders who may or may not work in the healthcare or research fields seeks to empower those members with the education to inform their communities and increase representation in science. Designed for increasing education, dispelling common misperceptions, and an easy format, these modules are expected to increase the reach of research into historically underrepresented communities. Citation Format: Jennifer M. Crook, Opeyemi Bolajoko, Barbara Greguson, Gwen Boe, Karen Young, Katrina Croghan, Folakemi Odedina. Increasing the arm of research by finding and training key community stakeholders: The Mayo Clinic "Community Engagement in Research and Clinical Trial (CERCT)" curriculum phase 2 [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A086.

Using a chat-based informed consent tool in large-scale genomic research.

We implemented a chatbot consent tool to shift the time burden from study staff in support of a national genomics research study. We created an Institutional Review Board-approved script for automated chat-based consent. We compared data from prospective participants who used the tool or had traditional consent conversations with study staff. Chat-based consent, completed on a user's schedule, was shorter than the traditional conversation. This did not lead to a significant change in affirmative consents. Within affirmative consents and declines, more prospective participants completed the chat-based process. A quiz to assess chat-based consent user understanding had a high pass rate with no reported negative experiences. Our report shows that a structured script can convey important information while realizing the benefits of automation and burden shifting. Analysis suggests that it may be advantageous to use chatbots to scale this rate-limiting step in large research projects.

Informed Consent: Mechanical thrombectomy for intermediate risk pulmonary embolism

An informed consent article using a set of publications to develop an informed consent conversation for a patient with an acute pulmonary embolism being considered for pulmonary artery thrombolysis.

Informed consent for image-guided procedures: a nationwide survey of perceptions and current practices

To characterise the current landscape of informed consent practices for image-guided procedures, including location of consent, guideline availability, and utility of decision-aid resources. A survey of 159 interventional radiologists was conducted from April through June 2022. The survey evaluated participant demographics (gender, practice type, and level of training) and consent practices. Fifteen questions investigated discussion of benefits, risks, and alternatives, who obtained consent, location of consent conversations, how decision-making capacity is assessed, availability of formal guidance on consent discussions, and if and how decision-aids are used. Most respondents (93.7%) were "extremely" or "very" comfortable discussing the benefits and risks of image-guided procedures during informed consent. Most respondents were "very" comfortable discussing alternative treatments within radiology (86.8%) while fewer felt confident regarding alternatives outside radiology (46.5%). Most respondents indicated obtaining consent in a pre-procedure area (89.9%), while 12.7% of respondents obtained consent in the procedure room. Of the respondents, 66.7% did not have formal education or documented guidance on what providers should disclose during consent. Ninety-two respondents (57.9%) reported using decision aids. The type of decision aid varied, with most reporting using illustrations or drawings (46.6%). Decision aid utility was more prevalent in non-teaching/academic (71.4%) versus academic (61%) institutions (p=0.02). Regardless of demographics, interventionalists are confident in discussing benefits, risks, and alternative image-guided therapies, but are less confident discussing alternative treatment options outside of radiology. Formal education on informed consent is less common, and the use of decision aids varies between teaching and non-teaching institutions.

Informed consent in episiotomy: Co-analysis with midwives and distillation of best practice.

Performing an episiotomy where clinically indicated is a key intervention in the Obstetric Anal Sphincter Injury Care Bundle (OASI-CB) implemented across England and Wales to reduce the risk and increase the detection of severe perineal trauma after birth. Standards of consent provided to people in maternity care generally and for episiotomy specifically have been reported as suboptimal. Compromising birthing people's personal autonomy or sense of control has been linked to a dissatisfying birth experience, negative psychological sequelae, and litigation. This study explored experienced midwives' practice of informed consent for episiotomy during a midwife-led birth. We sampled 43 midwives across eight NHS Trusts in England and Wales using online focus groups and telephone interviews about their experience of consent in episiotomy. Using qualitative content analysis and art-based co-analysis methods with eight midwives from across the research sites, we co-analyzed and co-constructed three themes and four practice recommendations from the data. Three themes were constructed from the data: Assent rather than consent, Change in culture to support best practice, and Standardized information. These themes informed the shaping of four recommendations for best practice in episiotomy informed consent. This study has shown how variations in midwifery practice and culture may impact birthing people's experience of informed consent in episiotomy. Midwives may not have the knowledge or skills to conduct a detailed consent conversation, leading to variation in practice and messages for birthing people. The use of antenatal discussion aids can offer women the opportunity to become informed and fully participate in the decision-making process.

Personalized surgical informed consent with stereoscopic visualization in neurosurgery—real benefit for the patient or unnecessary gimmick?

BackgroundInformed consent of the patient prior to surgical procedures is obligatory. A good and informative communication improves patients’ understanding and confidence, thus may strengthen the patient-doctor relationship. The aim of our study was to investigate the usefulness of additional stereoscopic visualization of patient-specific imaging during informed consent conversation.MethodsPatients scheduled for a brain tumor surgery were screened for this study prospectively. The primary exclusion criteria were cognitive or visual impairments. The participants were randomized into two groups. The first group underwent a conventional surgical informed consent performed by a neurosurgeon including a demonstration of the individual MRI on a 2D computer screen. The second group received an additional stereoscopic visualization of the same imaging to explain the pathology more in-depth. The patients were then asked to fill in a questionnaire after each part. This questionnaire was designed to assess the potential information gained from the patients with details on the anatomical location of the tumor as well as the surgical procedure and possible complications. Patients’ subjective impression about the informed consent was assessed using a 5-point Likert scale.ResultsA total of 27 patients were included in this study. After additional stereoscopic visualization, no significant increase in patient understanding was found for either objective criteria or subjective assessment. Participants’ anxiety was not increased by stereoscopic visualization. Overall, patients perceived stereoscopic imaging as helpful from a subjective perspective. Confidence in the department was high in both groups.ConclusionStereoscopic visualization of MRI images within informed consent conversation did not improve the objective understanding of the patients in our series. Although no objective anatomical knowledge gain was noted in this series, patients felt that the addition of stereoscopic visualization improved their overall understanding. It therefore potentially increases patient confidence in treatment decisions.

“Your child needs surgery”: A survey-based evaluation of simulated expert consent conversations by key stakeholders

BackgroundConsent conversations in pediatric surgery are essential components of pre-operative care which, when inadequate, can lead to significant adverse consequences for the child, parents, surgeon, and others in the healthcare system. The aim of this study is to explore expert consenting practice from the key stakeholders' perspective. MethodsFour senior attending pediatric surgeons obtained consent from a standardized mother of a child requiring surgery in two scenarios: a low-risk elective surgery (inguinal hernia repair – Video 1), and a high-risk emergency surgery (intestinal atresia – Video 2). All sessions were recorded. Families of children who had undergone minor or major surgery, families without medical or surgical background, and healthcare professionals were invited to view and evaluate the videos using a semi-structured questionnaire. ResultsOut of 251 distributed surveys, 56 complete responses were received. Thirty two participants (57.1%) evaluated video 1 and 24 (42.9%) evaluated. Overall, 22 (69%) respondents to video 1 and 20 (84%) respondents to video 2 were “very satisfied” with the recorded consent conversation. Qualitative responses shared common themes of valuing surgeon empathy, good surgeon communication, patient engagement, and adequate time and information. Suggestions for improvement included additional resources and visual aids, improved patient engagement, and discussion of post-operative expectations. ConclusionOur data identifies strengths and gaps in the current consent process from the perspective of patient families and providers. Identified areas for improvement in the informed consent process based on multi-stakeholder input will guide the planned development of a consenting educational video resource. Level of EvidenceIV.

Patient perspectives on intraoperative blood transfusion: A qualitative interview study with perioperative patients.

While red blood cell (RBC) transfusions are frequently administered during surgery, little is known about patient perspectives regarding intraoperative transfusion. The aim of this study was to understand patient perspectives about intraoperative RBC transfusion and explore their willingness to engage in transfusion prevention strategies. This descriptive qualitative study used semi-structured patient interviews before and after surgery. Purposive sampling was used to select adult patients with varying perioperative courses, including having perioperative transfusion or postoperative anemia. Inductive and deductive thematic analyses were conducted to identify themes. Twenty patients (nine preoperative and 11 postoperative patients) were interviewed. The following themes were identified: Risk-benefit perception of transfusion, transfusion acceptance, trust, patient involvement in transfusion decisions, acceptance of transfusion prevention interventions, and communication. Patients perceived transfusions as low-risk compared to the surgery itself. Factors influencing transfusion acceptance included trust in the healthcare system and the perception of the treatability of transfusion-related complications. Some patients preferred to defer transfusion decision making to the perioperative team, citing trust in professional judgment and building a positive relationship with their surgeon. Others wished for their preferences to be incorporated into transfusion decisions. Some desired detailed blood consent conversations and most were willing to participate in strategies to reduce intraoperative transfusion. In our sample, patients consider intraoperative transfusions as low-risk high-reward interventions and trust the healthcare system and perioperative team to guide intraoperative transfusion decision making. However, preoperative transfusion consent discussions were recalled as being superficial and lacking nuance. Targeted strategies are required to improve blood consent discussions to better integrate patient preferences.

Community-engaged training in informed consent.

Inadequate training in the interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research recruitment and retention. To address this critical gap, Tufts Clinical and Translational Science Institute developed regular trainings for clinical research coordinators and other research staff on the practical skills of communicating informed consent using community members as simulated patients for role-playing exercises. In this paper, we assess the reach and effectiveness of these trainings and describe the impact of employing community stakeholders as simulated patients. We found that by embedding community members in the trainings, clinical research coordinators get to hear diverse perspectives, experience a range of patient responses, and learn from the lived experience of the communities that research tries to serve. Utilizing community members as trainers also helps to dismantle traditional power dynamics by demonstrating the organization's commitment to inclusiveness and community engagement. Based on these findings, we suggest that training on informed consent include more simulated consent exercises that feature interaction with community members who can provide real-time feedback to coordinators.

Parental Preferences Surrounding Timing and Content of Consent Conversations for Clinical Germline Genetic Testing Following a Child's New Cancer Diagnosis.

Clinical genomic testing is increasingly being used to direct pediatric cancer care. Many centers are interested in offering testing of tumors and paired germline tissues at or near the time of cancer diagnosis. We conducted this study to better understand parent preferences surrounding timing and content of consent conversations for clinical germline genetic testing of their children with cancer as a part of real-time cancer care. A seven-question survey developed by the Division of Cancer Predisposition and collaborators at St Jude Children's Research Hospital (St Jude) was distributed to members of the St Jude Patient Family Advisory Council, which included parents of childhood cancer survivors and bereaved parents whose children with cancer had died. Parents were asked to provide free text comments after each question. Qualitative methods were used to derive codes from parent comments, and survey results were depicted using descriptive statistics. The survey was completed by 172 parents. Ninety-three (54%) endorsed an approach for consent conversations ≥ 1 month after cancer diagnosis, whereas 58 (34%) endorsed an approach at 1-2 weeks and 21 (12%) at 1-2 days. Needing time to adjust to a new or relapsed cancer diagnosis and feeling overwhelmed were frequent themes; however, parents acknowledged the urgency and importance of testing. Parents desired testing of as many cancer-related genes as possible, with clinical utility the most important factor for proceeding with testing. Most parents (75%) desired germline results to be disclosed in person, preferably by a genetic counselor. Parents described urgency and benefits associated with germline testing, but desired flexibility in timing to allow for initial adjustment after their child's cancer diagnosis.

Abstract No. 5 Use of decision support aids to improve informed consent for interventional radiology procedures: a randomized controlled trial

To assess the impact of giving standardized, vetted decision aids to patients prior to consent conversations for interventional radiology (IR) procedures on their understanding and satisfaction

Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in the ACROBAT pilot trial for severe postpartum haemorrhage

ObjectiveThe ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent....

"They are Assuming That We are Going to Accuse Them of Rape, and We are Assuming That They are Going to Rape us": A Developmental Perspective on Emerging Adults' Consent Conversations Post #MeToo.

Prevalence of sexual assault remains high on American college campuses, and sexual consent education is lacking within school-based sexual health education programming. Much empirical research has aimed to reduce sexual violence through a deeper understanding of college students' perceptions of sexual consent. However, researchers have not yet examined the impact of broader social discourse, such as that initiated by the #MeToo movement, on emerging adults' conceptualizations of sexual consent. Gendered focus groups were conducted with 34 college students at a large midwestern university in spring of 2019. Qualitative analyses using a phenomenological framework revealed a developmental process of consent education shaped by socialized sexual scripts and public discourse of the #MeToo movement. Four distinct themes emerged: (1) Introductions to Consent in Childhood, (2) Lack of Sexual Consent Education in Adolescence, (3) The Nuanced College Context, and (4) Consent in the Era of #MeToo. Findings reveal that consent is introduced in childhood, outside the context of sexuality, but is generally not revisited within the context of sexual consent by parents or educators during adolescence, leaving media messaging and socialized sexual scripts to serve as guides for sexual consent. This lack of sexual consent education in adolescence then leaves emerging adults unprepared for nuanced sexual experiences in the college context and unable to critically engage with public discourse surrounding consent such as the #MeToo movement, which has caused both fearful and positive outcomes. Findings support the need for earlier and more comprehensive education about sexual consent in childhood and adolescence and the need for college sexual assault prevention programs to include further instruction on navigating ambiguous sexual consent experiences.

Checklist-based Training Improves Consenting Skills Among Radiology Residents

This study aimed to demonstrate whether a curriculum based on an informed consent conversation checklist led to improvement in a resident's ability to obtain patient centered and legally sound consent. In this prospective, IRB approved study, Radiology residents from a single institution were asked to obtain informed consent for an imaging study or image-guided procedure from a standardized patient (SP). Encounters were scored by an attending radiologist on a 20-point checklist as well as by the SPs on four consent related questions. Residents were then provided reading material, a lecture, and a consent checklist pocket card. Residents participated in a post-intervention SP encounter. Wilcoxon Signed-Ranks Test was performed to determine if there was a significant improvement in scores after intervention. Twenty-one residents completed all aspects of the program. There was statistically significant improvement in consenting skills as measured by the attending scores and the SP scores after receiving formal education. Pre-intervention scores had a mean of 9.29 of 20 (SD 1.39), while post-intervention scores had a mean of 16.95 of 20 (SD 1.83). 95.2% (20/21) of residents found the training useful and stated they would recommend it to future trainees. Checklist-based consent training improved radiology residents' ability to obtain informed consent.

A qualitative exploration of obtaining informed consent in medical consultations with Burma-born women.

Conciliatory attitudes, respect for medical professionals and avoidance of being direct can make health consultations with Burma-born patients difficult to navigate. Coupled with linguistic barriers, this may make the sensitive nature of many women's health consultations challenging. Little is known about current practices for obtaining informed consent in this context. The objectives of this study were to explore current practices, barriers and strategies to obtaining informed consent in medical consultations with women born in Burma. Purposive and snowball sampling was used to recruit health practitioners (n =15, 2 male, 13 female) of different ages, years of professional experience, and country of origin, from clinics in Victoria that see a high volume of Burma-born patients. Thirty to sixty minute semi-structured interviews were conducted with four general practitioners, eight nurses and three interpreters, and de-identified audio recordings were transcribed for inductive thematic analysis. Five key themes were generated: (1) cultural cognisance; (2) influence of community; (3) skilful navigation of communication; (4) favourable consultation attributes; and (5) individual tailoring of consent conversations. Differing cultural expectations, and linguistic and educational barriers, were highlighted as challenges to obtaining informed consent, whereas thoughtful utilisation of non-verbal communication, and intentional customisation of consent conversations were identified as facilitators. The findings of this study provide practical ways to optimise the informed consent process within the Australian primary healthcare context, and reinforce that accepted Western-based practices for obtaining informed consent are not a 'one-size-fits-all' process.