The Surgical Clerkship in the COVID Era: A Natural Language Processing and Thematic Analysis.

INTRODUCTION: Responses to COVID-19 within medical education prompted significant changes to the surgical clerkship. We analyzed the changes in medical student end of course feedback before and after the COVID-19 outbreak. METHODS: Postclerkship surveys from 2017 to 2022 were analyzed including both Likert scale data and free text, excluding the COVID outbreak year 2019-2020. Likert scale questions were compared between pre-COVID (2017-2019) and COVID-era cohorts (2020-2022) with the Mann-Whitney U-test. Free-text comments were analyzed using both thematic analysis and natural language processing including sentiment, word and phrase frequency, and topic modeling. RESULTS: Of the 483 medical students surveyed from 2017 to 2022, 297 responded (61% response rate) to the included end of clerkship surveys. Most medical students rated the clerkship above average or excellent with no significant difference between the pre-COVID and COVID-era cohorts (70.4% Versus 64.8%, P = 0.35). Perception of grading expectations did significantly differ, 51% of pre-COVID students reported clerkship grading standards were almost always clear compared to 27.5% of COVID-era students (P = 0.01). Pre-COVID cohorts more frequently mentioned learning and feedback while COVID-era cohorts more frequently mentioned case, attending, and expectation. Natural language processing topic modeling and formal thematic analysis identified similar themes: team, time, autonomy, and expectations. CONCLUSIONS: COVID-19 presented many challenges to undergraduate medical education. Despite many changes, there was no significant difference in clerkship satisfaction ratings. Unexpectedly, the greater freedom and autonomy of asynchronous lectures and choice of cases became a highlight of the new curriculum. Future research should investigate if there are similar associations nationally with a multi-institutional study.

Surgical Residents as Clerkship Scholars May Improve Student Perception of the Surgery Clerkship.

INTRODUCTION: The surgical clerkship is a formative experience in the medical school curriculum and can leave a lasting impression on students' perception of surgery. Given the historical negative stereotypes of surgeons, the clerkship represents an opportunity to impact students in a meaningful way. METHODS: Our institution developed a program in which research residents can serve as junior clerkship coordinators and educators; working closely with medical students on their surgery clerkship. At the end of their clerkship, students were administered a survey with Likert-scale and free text responses regarding satisfaction with the rotation, lectures, feedback, and value of the clerkship. Student survey results were compared before (2015-2016) and after (2017-2019) the implementation of the scholar program with nonparametric statistical analysis and qualitative text analysis. RESULTS: A total of 413 students responded to the survey with no significant difference in response rate by term (P = 0.88). We found no statistical difference with respect to overall course perception (92.3% versus 91.2%, P = 0.84), but a statistically significant difference was noted for the clarity of the provided written clerkship materials (80.3% versus 91.3%, P = 0.02) and usefulness of the feedback (57.5% versus 78.7%, P = 0.01). Qualitative analysis demonstrated an overall positive shift in perception of the clerkship, improvement in the course materials, and organization. CONCLUSIONS: The scholar program was overall well received by the students with improvements in certain aspects of the clerkship: organization, feedback, and course materials. This program represents a potential strategy to improve certain portions of the medical school clerkship experience.

Contralateral Prophylactic Mastectomy Decision-Making: The Partners' Perspective.

BACKGROUND: The rate of contralateral prophylactic mastectomy (CPM) continues to rise despite no improvement in survival, an increased risk of surgical complications, and negative effects on quality of life. This study explored the experiences of the partners of women who undergo CPM. METHODS: This study was part of an investigation into the factors motivating women with early-stage unilateral breast cancer and low genetic risk to opt for contralateral prophylactic mastectomy (CPM). Participating women were asked for permission to invite their partners to take part in interviews. In-depth interviews with partners were conducted using a semi-structured topic guide. A thematic analysis of the data was performed RESULTS: Of 35 partners, all men, 15 agreed to be interviewed. Most perceived their role to be strong and logical. Some hoped their wives would choose a bilateral mastectomy. All felt strongly that the final decision was up to their partners. The partners often framed the decision for CPM as one of life or death. Thus, any aesthetic effects were unimportant by comparison. The male partners had difficulty grasping the physical and emotional changes inherent in mastectomy, which made communicating about sexuality and intimacy very challenging for the couples. In the early recovery period, some noted the stress of managing home life. CONCLUSIONS: The experiences of the male partners provide insight into how couples navigate complex treatment decision-making, both together and separately. There may be a benefit to including partners in pre- and post-surgical counseling to mitigate miscommunication regarding the expected oncologic and emotional outcomes related to CPM.

Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.

BACKGROUND: Collateral findings in pragmatic clinical trials are findings that may have implications for patients' health but were not generated to address a trial's primary research questions. It is uncertain how best to communicate these collateral findings to patients. OBJECTIVES: To determine how reactions to a letter communicating collateral findings relate to who signed the letter, the type of finding, or whether the letter specified that the finding arose from a pragmatic clinical trial. RESEARCH DESIGN: Web-based survey experiment using a between-subjects design in which respondents were randomly assigned within education strata to view and respond to 1 of 16 hypothetical scenarios. SUBJECTS: Adults recruited from an online panel constructed from a probability sample of US-based postal addresses. MEASURES: The primary outcomes were the action the respondent would take next (i.e., contact a doctor immediately or something else) and the respondent's emotional reactions (i.e., all positive, all negative, mixed, or none). RESULTS: A total of 4080 respondents had analyzable data. Although some effects were statistically significant (P < .05), none exceeded a prespecified threshold for policy relevance (15 or more percentage points). Ratings of letter clarity and level of understanding were lower for letters that included a description of the clinical trial. CONCLUSIONS: Signatory and level of detail about collateral findings did not substantially affect people's intentions to take the recommended action of contacting their doctor. Deciding whether to include a description of the pragmatic clinical trial requires a trade-off between transparency and more difficulty understanding the contents of the letter.

Reframing the conversation about contralateral prophylactic mastectomy: Preparing women for postsurgical realities.

OBJECTIVE: Women with unilateral, early-stage breast cancer and low genetic risk are increasingly opting for contralateral prophylactic mastectomy (CPM), a concerning trend because CPM offers few clinical benefits while increasing risks of surgical complications. Few qualitative studies have analyzed factors motivating this irreversible decision. Using qualitative methods, this study sought to understand women's decision making and the impact of CPM on self-confidence, sense of femininity, sexual intimacy, and peace of mind. METHODS: Women who had CPM within the last 10 years were recruited to participate in the study. We conducted a thematic analysis of the data. RESULTS: Forty-five women were interviewed. When making the decision for CPM, most had incomplete knowledge of potential negative outcomes. However, all believed CPM had more benefits than harms and would confer the most peace of mind and the fewest regrets should cancer return. They knew their contralateral breast cancer risk was low but were not persuaded by statistics. They wanted to do everything possible to reduce their risk of another breast cancer, even by a minimal amount, but most reported paying an unexpectedly high price for this small reduction in risk. Nevertheless, 41 of 45 reported that they would make the same decision again. CONCLUSIONS: These findings highlight an opportunity for physicians to reframe the conversation to focus on the patient experience of the tradeoffs of CPM rather than statistical odds of future cancers. Our findings suggest that more data may not dissuade women from CPM but may better prepare them for its outcomes.

Exploring patient-provider decision-making for use of anticoagulation for stroke prevention in atrial fibrillation: Results of the INFORM-AF study.

BACKGROUND: Atrial fibrillation is associated with stroke, yet approximately 50% of patients are not treated with guideline-directed oral anticoagulants (OACs). AIMS: Given that the etiology of this gap in care is not well understood, we explored decision-making by patients and physicians regarding OAC use for stroke prevention in atrial fibrillation. METHODS AND RESULTS: We conducted a descriptive qualitative study among providers ( N=28) and their patients with atrial fibrillation for whom OACs were indicated ( N=25). We used purposive sampling across three outpatient settings in which atrial fibrillation patients are commonly managed: primary care ( n=14), geriatrics ( n=10), and cardiology ( n=4). Eligible patients were stratified by those prescribed OAC ( n=13) and not prescribed OAC ( n=12). Semi-structured, in-depth interviews assessed decision-making regarding risk and OAC use. Classical content analysis was used to code narratives and identify themes. Results among patients consisted of the overarching theme of trust in provider recommendations. Sub-themes included: awareness of increased risk of stroke with atrial fibrillation; willingness to accept medications recommended by their physician; and low demand for explanatory decision aids. Among physicians, the overarching theme was decisional conflict regarding the balance between stroke and bleeding risk, and the optimal medication to prescribe. Subthemes included: absence of decision aids for communication; and misperceptions around the assessment and management of stroke risk with atrial fibrillation. CONCLUSIONS: Patient involvement in decision-making around OAC use did not occur in this study of patients with atrial fibrillation. Improved access to decision aids may increase patient engagement in the decision-making process of OAC use for stroke prevention.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

OBJECTIVE: To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. METHODS: In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. RESULTS: Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. CONCLUSIONS: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Oncology providers' perspectives on endocrine therapy prescribing and management.

PURPOSE: Adjuvant endocrine therapy (ET) can reduce the risk of recurrence among females with hormone receptor-positive breast cancer. Overall, initiation and adherence to ET are suboptimal, though reasons are not well described. The study's objective was to better understand ET decision making, prescribing, and patient management from oncology providers' perspectives. METHODS: Using purposive sampling, we recruited oncology providers who saw five or more breast cancer patients per week (n=20). We conducted 30-45-minute telephone interviews, using a semistructured guide to elicit perspectives on ET use. We used thematic content analysis to systematically identify categories of meaning and double-coded transcripts using Atlas.ti. RESULTS: Providers recommend ET to all eligible patients except those with contraindications or other risk factors. Providers base their ET prescribing decisions on the patient's menopausal status, side effects, and comorbidities. ET is typically discussed multiple times: at the onset of breast cancer treatment and in more detail after other treatment completion. Providers felt that the associated recurrence risk reduction is the most compelling argument for patients during ET decision making. While providers rarely perceived noninitiation as a problem, nonadherence was prevalent, often due to unresolvable side effects. CONCLUSION: From the clinicians' perspectives, side effects from ET are the dominant factor in nonadherence. Efforts to improve adherence should focus on strategies to minimize side effects and ensure clinicians and patients are well informed regarding optimal side effect management. This finding has important implications for novel endocrine regimens that offer improved outcomes through longer duration or more intensive therapy.

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis.

OBJECTIVES: To explore patient, caregiver and physician perceptions and attitudes regarding the balance of benefit and risk in using antibacterial drugs developed through streamlined development processes. DESIGN: Semistructured focus groups and in-depth interviews were conducted to elicit perceptions and attitudes about the use of antibacterial drugs to treat multidrug-resistant infections. Participants were given background information about antibiotic resistance, streamlined drug development programmes and FDA drug approval processes. Audio recordings of focus groups/interviews were reviewed and quotes excerpted and categorised to identify key themes. PARTICIPANTS: Two primary stakeholder groups were engaged: one comprising caregivers, healthy persons and patients who had recovered from or were at risk of resistant infection (N=67; 11 focus groups); and one comprising physicians who treat resistant infections (N=23). RESULTS: Responses from focus groups/interviews indicated widespread awareness among patients/caregivers and physicians of the seriousness of the problem of antibacterial resistance. Both groups were willing to accept a degree of uncertainty regarding the balance of risk and benefit in a new therapy where a serious unmet need exists, but also expressed a desire for rigorous monitoring and rapid, transparent reporting of safety/effectiveness data. Both groups wanted to ensure that >1 physician had input on whether to treat patients with antibiotics developed through a streamlined process. Some patients/caregivers unfamiliar with exigencies of critical care suggested a relatively large multidisciplinary team, while physicians believed individual expert consultations would be preferable. Both groups agreed that careful oversight and stewardship of antibacterial drugs are needed to ensure patient safety, preserve efficacy and prevent abuse. CONCLUSIONS: Groups comprising patients/caregivers and physicians were aware of serious issues posed by resistant infections and the lack of effective antibacterial drug therapies and shared a consensus that streamlined development programmes represent a necessary response to the resistance crisis, but one that requires enhanced safeguards and risk communication.

Using Telehealth to Train Providers of a Cancer Support Intervention.

BACKGROUND: Group interventions are effective for addressing the transition from cancer treatment to survivorship but are not widely available outside of urban areas. In addition, minimal training is available for group facilitators outside of the mental healthcare discipline. Telehealth as a medium can facilitate conversation and interactive learning and make learning accessible to individuals in areas that lack resources for traditional classroom teaching. Little is known, however, regarding the feasibility and acceptability of a telehealth training program for group leaders. This project aimed to investigate the utility of a telehealth training program for the delivery of a copyrighted, manualized psychosocial group intervention, Cancer Transitions: Moving Beyond Treatment. MATERIALS AND METHODS: Nine group leaders attended one in-person orientation, four telehealth training classes, and four telehealth supervision sessions, completing self-report measures of content knowledge, quality satisfaction, and self-confidence. Following the completion of their last Cancer Transitions facilitation, group leaders participated in a focus group to provide qualitative feedback regarding their experiences in training for and leading the respective groups in eight urban and rural North Carolina communities. RESULTS: Group leaders rated the training program highly across the domains of content knowledge, quality satisfaction, and self-confidence. Satisfaction with the technology itself was equivocal. CONCLUSIONS: Telehealth represents a feasible avenue for training and supporting leaders of psychosocial interventions. In addition, telehealth is particularly well suited to the need for training group leaders in areas outside urban centers or academic communities.

Beliefs and perceptions of women with newly diagnosed breast cancer who refused conventional treatment in favor of alternative therapies.

PURPOSE: Although breast cancer is a highly treatable disease, some women reject conventional treatment opting for unproven "alternative therapy" that may contribute to poor health outcomes. This study sought to understand why some women make this decision and to identify messages that might lead to greater acceptance of evidence-based treatment. PATIENTS AND METHODS: This study explored treatment decision making through in-depth interviews with 60 breast cancer patients identified by their treating oncologists. Thirty refused some or all conventional treatment, opting for alternative therapies, whereas 30 accepted both conventional and alternative treatments. All completed the Beck Anxiety Inventory and the Rotter Locus of Control scale. RESULTS: Negative first experiences with "uncaring, insensitive, and unnecessarily harsh" oncologists, fear of side effects, and belief in the efficacy of alternative therapies were key factors in the decision to reject potentially life-prolonging conventional therapy. Refusers differed from controls in their perceptions of the value of conventional treatment, believing that chemotherapy and radiotherapy were riskier (p < .0073) and less beneficial (p < .0001) than did controls. Controls perceived alternative medicine alone as riskier than did refusers because its value for treating cancer is unproven (p < .0001). Refusers believed they could heal themselves naturally from cancer with simple holistic methods like raw fruits, vegetables, and supplements. CONCLUSION: According to interviewees, a compassionate approach to cancer care plus physicians who acknowledge their fears, communicate hope, educate them about their options, and allow them time to come to terms with their diagnosis before starting treatment might have led them to better treatment choices.