Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

INTRODUCTION: While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. METHODS: A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. RESULTS: There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. CONCLUSION: Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Setting Intentions.

In this narrative medicine essay, an oncologist ruminates over a chemotherapy consent form about the goals of therapy for a young adult whose body is filled with an aggressive cancer most commonly seen in children.

Factors impacting informed consent in cosmetic breast augmentation.

BACKGROUND: For women who undergo cosmetic breast augmentation, their post-operative risk assessment may not match their pre-operative understanding of the involved risks and likelihood of revision surgeries. This may be due to the potential issues surrounding whether patients are being fully informed about all possible risks and related financial implications during the consent phases of patient/doctor consultation. METHODS: To explore comprehension, risk preference, and perceptions of breast augmentation procedure, we conducted a recorded online experiment with 178 women (18-40 years) who received varying amounts of risk-related information from two experienced breast surgeons in a hypothetical first consultation scenario. RESULTS: We find patient's age, self-rated health, income, education level, and openness to experience to be significant factors impacting initial breast augmentation risk preferences (before receiving any risk information). Further, more emotionally stable patients perceived greater breast augmentation risks, were less likely to recommend breast augmentation, and were more likely to acknowledge the likelihood for future revision surgery. After providing women with risk-related information we find increases in risk assessment in all treatment conditions, and that increased amounts of risk information do decrease women's willingness to recommend breast augmentation. But that increased risk information does not appear to increase women's assessment of the likelihood of future revision surgery. Finally, we find some participant individual differences (such as education level, having children, conscientiousness and emotional stability) appear to impact risk assessment post receiving risk information. CONCLUSION: Continuous improvement of the informed consent consultation process is vital to optimising patient outcomes efficiently and cost-effectively. Greater acknowledgement and emphasis on disclosure of related risks and financial burden when complications arise is also important. As such, future behavioural research is warranted into the factors impacting women's understanding both prior to and across the BA informed consent process.

The Evolving Story of Mesh Mid Urethral Slings: The Surgeon's Perspective.

PURPOSE: The objective of this study was to obtain the perspectives of surgeons who treat female stress urinary incontinence (SUI) and better understand their range of experiences with mesh mid urethral sling (MUS) surgery. MATERIALS AND METHODS: This qualitative study recruited gynecologic and urological surgeons who treat SUI. Surgeons were interviewed by phone and in person using a standardized interview guide. Interviews were transcribed, de-identified, and analyzed by 2 independent researchers. The transcripts were coded and summarized using the principles of thematic analysis. The research team came to consensus that a saturation of ideas representing a diverse demographic of surgeons had been achieved. RESULTS: Twenty-four interviews of surgeons from diverse geographic locations and practice types were performed. Many surgeons described MUS surgery as rewarding and favorably impactful for women with SUI, while others grappled with the serious risks associated with MUS surgery. Those who had treated women with life-altering pain after MUS recounted impactful patient stories. Many stated that recognition, acknowledgement, and appropriate referral of complications were fundamental to responsible and ethical care. Some surgeons expressed frustration and concern about the raised level of controversy and anxiety regarding the MUS landscape. All participants expressed that there was substantial room for improvement in multiple domains. Participants also shared their optimal strategies relevant to MUS surgery. CONCLUSIONS: Despite diverse views regarding the role of the MUS, there was agreement among surgeons that the surgeon-patient relationship, thorough informed consent and patient counseling, and accountability are essential when implanting MUSs.

Informed Consent and Informed Decision-Making in High-Risk Surgery.

Surgeons are more likely to focus on consent protocols than patients' decision needs.

Research Involving Participants With Impaired Consent Capacity: An Examination of Methods to Determine Capacity to Consent.

OBJECTIVE: To examine methods of assessing consent capacity in research protocols involving participants with impaired consent capacity, and examine instruments used to evaluate research consent capacity. METHODS: A retrospective review of 330 active research protocols involving participants lacking capacity to consent over a 10-year period (January 1, 2009, through March 1, 2019) was conducted to collect protocol characteristics (medical specialty, level of risk and type of study, consent and assent procedures, and type of vulnerable or protected population). Methods to assess consent capacity are described, and instruments to assess consent capacity are summarized. RESULTS: The specialties most frequently involving participants with impaired consent capacity in research were Neurology (27.3%), Critical Care (16.7%), and Surgery (10%). Type of studies are observational (43.9%), clinical trials (33%), chart review (11.5%), biobank (6.1%), and biomarker (5.5%). Minimal risk (53.3%) outnumbered greater than minimal risk (46.7%) studies. Most obtained written informed consent (77%) and assent (40.9%). The most common method to assess consent capacity was direct assessment by investigators (32.7%). Only 86 (26%) studies used instruments to assess consent capacity. Of the 13 instruments used, the most common was the Evaluation of Decision-Making Capacity for Consent to Act as a Research Subject, and is the only instrument that assesses all four components of decisional capacity: understanding, appreciation, reasoning, and choice. CONCLUSION: Generally, there was lack of uniformity in determining capacity to consent to research participation. Very few studies used instruments to assess consent capacity. Institutional review boards can provide greater guidance for research consent capacity determination.

Do the Potential Medical Benefits of Phase 1 Pediatric Oncology Trials Justify the Risks? Views of the United States Public.

OBJECTIVES: To assess the US public's views on whether the potential medical benefits of phase 1 pediatric oncology trials justify the risks. STUDY DESIGN: Online survey of a nationally representative sample of US adults. Participants were presented with a hypothetical scenario in which they have a 10-year-old child with advanced cancer. They were then offered the option of giving their child supportive care or trying one more potential treatment, in the research or clinical care setting, which has the same risks and potential medical benefits as the average phase 1 pediatric oncology trial. We assessed what percentage of respondents thought the potential medical benefits justify the risks. RESULTS: In total, 1658 of the 2508 individuals who were sent the survey participated (response rate = 66.1%). Of those who passed all 3 test questions indicating understanding, 67.1% in the research scenario and 58.5% in the clinical care scenario regarded the potential medical benefits of an average phase 1 pediatric oncology trial as equal to or greater than the risks. In addition, 53.4% of respondents in the research scenario thought it was appropriate for researchers to conduct a study in children with these risks and potential medical benefits, and 46.9% stated they would enroll their own child in such a trial. CONCLUSIONS: A majority of the US public regards the potential medical benefits of average phase 1 pediatric oncology trials as justifying the risks. This finding suggests that these trials are ethically appropriate and approvable in patients who have no more effective treatment options. At the same time, a significant minority thought the potential medical benefits do not justify the risks, suggesting these trials should be approved only when they have significant social value. Moreover, approximately one-half of respondents regarded the trials as inappropriate and would not enroll their own child, underscoring the need for a rigorous informed consent process that accurately educates parents regarding the risks, potential medical benefits, and alternatives, so they can decide whether to enroll their child based on their own preferences and goals.

Confidence level, challenges, and obstacles faced by orthopedic residents in obtaining informed consent.

OBJECTIVES: The objective is to evaluate the opinions of orthopedic residents on current practices, experiences, training, confidence level, difficulties, and challenges faced when obtaining informed consent. DESIGN: This is a cross-sectional, multi-center, and questionnaire-based study. SETTING: The study was done in forty-four training centers across Saudi Arabia. PARTICIPANTS: In total, 313 orthopedic residents participated. MATERIAL AND METHODS: The web-based questionnaire examined the perceptions of residents regarding practices, experience, training, difficulties, and challenges surrounding the obtention of informed consent, as well as residents' confidence in obtaining informed consent for different orthopedic situations and eight common orthopedic procedures. RESULTS: Most residents were allowed to obtain consent independently for all emergency, trauma, primary, and revision cases at their institution (92.7%). Only 33.5% of the residents received formal training and teaching on obtaining informed consent, with 67.1% having believed that they needed more training. Only 4.2% of the residents routinely disclosed all essential information of informed consent to patients. Inadequate knowledge (86.3%) and communication barriers (84.7%) were the most reported difficulties. Generally, 77.3% of the residents described their confidence level in obtaining informed consent as good or adequate, and 33.9% were confident to discuss all key components of the informed consent. Residents' confidence level to independently obtain informed consent decreased with procedure complexity. Receiving formal training, senior level (postgraduate year (PGY) 4 and 5), and being frequently involved in obtaining informed consent correlated with increased confidence level. CONCLUSION: Many residents incompletely disclosed key information upon obtaining informed consent and reported lacking confidence in their ability to perform the procedure in their daily practices. To improve patient care and residents' performance and overcome these difficulties and challenges, institutions should develop effective strategies to standardize the informed consent process, provide formal training for obtaining informed consent, and provide supervision for residents during obtention of informed consent.

Patient Reported Experience on Consenting for Surgery - Elective Versus Emergency Patients.

INTRODUCTION: Informed consent for surgery is a medical and legal requirement, but completing these does not necessarily translate to high patient satisfaction. This patient-reported experience study aimed to examine the surgical consent process, comparing the patients' experience in elective and emergency settings. METHODS: Over a 6-mo period, postoperative patients at The Alfred Hospital Breast and Endocrine Surgical Unit were invited to participate in a survey on the surgical consent process - including perceived priorities, information provided and overall experience. Standard statistical techniques were used, with a significant P-value of < 0.05. RESULTS: A total of 412 patients were invited, with 130 (32%) responses. More patients underwent elective surgery (N= 90, 69%) than emergency surgery (N = 40, 31%). Emergency patients were more likely to sign the consent form regardless of its contents (93% versus 39%, P < 0.001) and more likely to be influenced by external pressures (63% versus 1%, P < 0.001). Elective patients were more likely to want to discuss their surgery with a senior surgeon (74% versus 23%, P < 0.001) and more likely to seek advice from external sources (83% versus 10%, P < 0.001). Both groups highly valued the opportunity to ask questions (67% versus 63%, P = 0.65). CONCLUSION: This study shows patients have a range of different priorities in preparation for surgery. Therefore, each consent process should be patient-specific, and focus on providing the patient with quality resources that inform decision-making.

Patient comprehension necessary for informed consent for vascular procedures is poor and related to frailty.

OBJECTIVE: Informed consent is an essential principle of high-quality health care. A core component of surgical informed consent is patient comprehension of basic information such as the diagnosis, risks, benefits, and alternatives of the proposed surgery. We sought to assess informed consent among vascular surgery patients and the association between frailty, education, decisional conflict, and patient comprehension. METHODS: We tested patient comprehension of basic information required for informed consent with a procedure-specific questionnaire in 102 consecutive patients undergoing selected vascular surgery procedures. Two patients who underwent open aortic aneurysm repair were excluded because of small sample size. All patients underwent assessment using the decisional conflict scale and the Frail/Nondisabled questionnaire. Analyses were performed to determine relationships between being informed and frailty, education level, and decisional conflict score. Patients included in this cohort had a median age of 71 years, and 25%, 14%, 28%, and 33% underwent carotid endarterectomy, endovascular aortic aneurysm repair, dialysis access creation, and percutaneous lower extremity procedures. RESULTS: Overall, 14% of patients were classified as "informed" and correctly answered all questions. Procedure type (P = .001), consent obtained by the attending surgeon vs a trainee (P = .04), and frailty score (P = .005) were all associated with whether a patient was informed or not. However, after multivariable adjustment, only frailty score was independently associated with being informed (odds ratio, 0.54; 95% confidence interval, 0.30-0.95; P = .03). The median decisional conflict scale score was 7.8, suggesting that patients feel well informed and supported in spite of poor understanding of procedural indications, risks, benefits, and alternatives. CONCLUSIONS: As a group, patients have a poor comprehension of basic information related to surgical informed consent. These findings have potential ethical and clinical implications, and additional work is required to best determine causes of poor comprehension and strategies to mitigate the same.

Subject positions in screening mammography and implications for informed choice.

OBJECTIVE: Screening mammography has potential benefits as well as harms, but these are not always communicated to women. We therefore explored how women discuss screening mammography, the subject positions made available in their discourse, and the implications of these for informed choice. Design: We conducted 16 individual interviews with women aged 44-72 years who were attenders (n = 11) and non-attenders (n = 5) of screening, and analysed transcripts through Foucauldian Discourse Analysis. Main Outcome Measures: A semi-structured interview guide, informed by literature and researcher expertise, was used to collect data. Results: The women constructed screening mammography as either helpful or potentially harmful. We identified three subject positions-The Responsible Woman (who attends screening), The Irresponsible Woman (who does not attend screening), and the Judicious Woman (who engages in alternate breast health practices). Conclusion: These subject positions have the potential to limit women's choices, constrain shared decision-making with health professionals, and restrict women's engagement in risk-reducing behaviours. An expanded range of options ultimately offers an alternate future in which women's autonomy to control their own bodies is better supported.

Surgical Residents' Perspective on Informed Consent-How Does It Compare With Attending Surgeons?

BACKGROUND: The informed consent discussion (ICD) is a compulsory element of clinical practice. Surgical residents are often tasked with obtaining informed consent, but formal instruction is not included in standard curricula. This study aims to examine attitudes of surgeons and residents concerning ICD. MATERIALS AND METHODS: A survey regarding ICD was administered to residents and attending surgeons at an academic medical center with an Accreditation Council for Graduate Medical Education-accredited general surgery residency. RESULTS: In total, 44 of 64 (68.75%) residents and 37 of 50 (72%) attending surgeons participated. Most residents felt comfortable consenting for elective (93%) and emergent (82%) cases, but attending surgeons were less comfortable with resident-led ICD (51% elective, 73% emergent). Resident comfort increased with postgraduate year (PGY) (PGY1 = 39%, PGY5 = 85%). A majority of participants (80% attending surgeons, 73% residents) believed resident ICD skills should be formally evaluated, and most residents in PGY1 (61%) requested formal instruction. High percentages of residents (86%) and attendings (100%) believed that ICD skills were best learned from direct observation of attending surgeons. CONCLUSIONS: Resident comfort with ICD increases as residents advance through training. Residents acknowledge the importance of their participation in this process, and in particular, junior residents believe formal instruction is important. Attending surgeons are not universally comfortable with resident-led ICDs, particularly for elective surgeries. Efforts for improving ICD education including direct observation between attending surgeons and residents and formal evaluation may benefit the residency curriculum.

Consent in forefoot surgery; What does it mean to the patient?

AIMS: This study aimed to assess patient risk recall and find risk thresholds for patients undergoing elective forefoot procedures. METHODS: Patients were interviewed in the pre-assessment clinic (PAC) or on day of surgery (DOS); some in both settings. A standardised questionnaire was used for all interviews, regardless of setting. Patients were tested on which risks they recalled from their consent process, asked for thresholds for five pre-chosen risks and asked about a sham risk. RESULTS: Across all interviews, risk recall on DOS (2.34 risks/patient interview) was significantly lower (p=.05) than in PAC (2.95 risks/patient interview) - this was repeated when comparing results from patients interviewed in both settings only with PAC mean recall of 2.93 risks/patient interview and DOS mean recall of 2.57 risks/patient interview. The mean reported risk thresholds greatly exceeded NHS Lothian's observed complication rates for forefoot procedures. The five risks tested for thresholds produced the same order in each interview setting, suggesting a patient-perceived severity ranking. Patients answering the sham risk question incorrectly tended to recall fewer risks across all interviews. CONCLUSIONS: This study shows that patient risk recall is poor, as previous literature outlines, reinforcing that consent process improvements could be made. It also illustrates the value of PAC visits in patient education, as shown by higher levels of recall when compared to DOS.

Universal tumor screening for lynch syndrome: perspectives of patients regarding willingness and informed consent.

Aim: Lynch Syndrome is associated with a significant risk of colorectal carcinoma (CRC) and other cancers. Universal tumor screening is a strategy to identify high-risk individuals by testing all CRC tumors for molecular features suggestive of Lynch Syndrome. Patient interest in screening and preferences for consent have been underexplored. Methods: A postal survey was administered to CRC patients in a Canadian province. Results: Most patients (81.4%) were willing to have tumors tested if universal tumor screening were available and were willing to discuss test results with family members and healthcare professionals. The majority (62.6%) preferred informed consent be obtained prior to screening. Conclusion: Patients were supportive of universal screening. They expected consent to be obtained, contrary to current practice across Canada and elsewhere.

Parents'/Patients' Perception of the Informed Consent Process and Surgeons Accountability in Corrective Surgery for Adolescent Idiopathic Scoliosis: A Prospective Study.

STUDY DESIGN: Prospective study. OBJECTIVE: To determine the parents'/patients' perception on the informed consent process prior to posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) patients. SUMMARY OF BACKGROUND DATA: Understanding parents/patients perspective on the process is important in order to achieve the goal of consent and prevent medico-legal implications. METHODS: Fifty AIS patients operated between August 2019 and November 2019 were prospectively recruited. Parents'/patients' perceptions on three sections were evaluated: the process of the informed consent, specific operative risk which they were most concerned with and the accountability of surgeons for the surgical risks. These data were ranked and scored using a 5-point Likert Scale. Preferences were reported in mean and standard deviation. Differences in terms of preferences were studied using One-way analysis of variance (ANOVA) analysis and deemed significant when P < 0.05. RESULTS: There were 30 females (60.0%) and 20 males (40.0%) with a mean age of 41.8 ±â€Š10.6 years. Majority of parents/patients preferred the inform consent to be explained more than once (P = 0.021), once during clinic consultation and once during admission (4.2 ±â€Š1.0). Consent taking by both attending surgeons was preferred (4.5 ±â€Š0.6) compared with other healthcare providers, P < 0.001. Death (60.0%) and neurological deficit (30.0%) were the two most concerned surgical risks. Parents/patients would still hold the surgeon accountable for any complications despite signing the informed consent and they felt that surgeons were directly responsible for screw-related injuries (3.9 ±â€Š0.9), neurological injury (3.8 ±â€Š0.9), and intraoperative bleeding (3.7 ±â€Š0.9). CONCLUSION: Parents/patients preferred the attending surgeons to personally explain the informed consent, more than once with the use of visual aid. They would still hold the surgeons accountable when complications occur despite acceptance of the informed consent. LEVEL OF EVIDENCE: 2.

End-of-life decision-making capacity in an elderly patient with schizophrenia and terminal cancer.

Medical practitioners are confronted daily with decisions about patients' capacity to consent to interventions. To address some of the pertinent issues with these assessments, the end-of-life decision-making capacity of a 72-year-old female with treatment-resistant schizophrenia and terminal cancer is discussed, as are the role of the treating clinician and the importance of health-related values. There is a recommendation that the focus of these assessments can rather be on practical outcomes, especially when capacity issues arise. This implies that the decision-making capacity of the patient is only practically important when the treatment team is willing to proceed against the patient's wishes. This shifts the focus from a potentially difficult assessment to the simpler question of whether the patient's capacity will change the treatment approach. Clinicians should attend to any possible underlying issues, instead of focusing strictly on capacity. Compared to the general populations people with serious mental illness (SMI) have higher rates of physical illness and die at a younger age, but they do not commonly access palliative care services. Conversations about end-of-life care can occur without fear that a person's psychiatric symptoms or related vulnerabilities will undermine the process. More research about palliative care and advance care planning for people with SMI is needed. This is even more urgent in light of the coronavirus disease-2019 (COVID-19) pandemic, and South African health services should consider recommendations that advanced care planning should be routinely implemented. These recommendations should not only focus on the general population and should include patients with SMI.

Adolescent Brain Development and Medical Decision-making.

With a few notable exceptions, adolescents do not possess the legal authority to provide consent for or refuse medical interventions. However, in some situations, the question arises regarding whether a mature minor should be permitted to make a life-altering medical decision that would be challenged if made by the minor's parent. In this article, I explore what we currently know about the adolescent brain and how that knowledge should frame our understanding of adolescent decision-making. The prevailing approach to determining when adolescents should have their decisions respected in the medical and legal context, an approach that is focused on establishing capacity under a traditional informed consent model, will be reviewed and critiqued. I will suggest that the traditional model is insufficient and explore the implications for the adolescent role in health care decision-making.