Croghan, Ivana T.

Background: There is a lack of data regarding the current state of lactation accommodations at continuing medical education (CME) events to guide best practice recommendations. Objective: To evaluate CME attendee attitudes, experiences, and preferences as it pertains to lactation support accommodations at CME events. Design: A cross-sectional study utilizing an electronic-based survey. Methods: Surveys were administered electronically to attendees of seven CME courses from August 2022 to October 2023, and de-identified data were collected to a secure database. Attitudes regarding lactation accommodations, personal preferences for lactation accommodations, and experiences with lactation at CME events were analyzed. Results: Of the 337 survey respondents, 169 had personal experience with lactation and 47 had experience with lactation at a CME course within the past 10 years. The majority of respondents agreed that lactation accommodations should be a priority ( n = 264, 83%) and are a medical need ( n = 285, 89%). Of those with recent experience lactating at a CME course, only 19% ( n = 9) indicated adequate lactation accommodations were provided. Due to inadequate accommodations, 77% ( n = 36) of respondents experienced decreased participation in the CME course content, 70% ( n = 33) claimed fewer hours of CME credit, and 74% ( n = 35) experienced decreased satisfaction in the CME course. Preferences for lactation accommodations included proximity to the meeting, audio–visual streaming of content, privacy, security, and signage supporting lactation in addition to an adequate designated space with access to an electrical plug and water supply. Conclusions: The current state of lactation accommodations at CME courses is inadequate and contributes to inequitable experiences for lactating participants. Course participants are supportive of lactating healthcare professionals at CME courses and recognize lactation accommodations as a priority. Further work is needed to inform and institute changes to lactation accommodations for healthcare professionals.

Objectives: To investigate the association between hormone therapy use and severe outcomes due to COVID-19 in perimenopausal and postmenopausal women. Methods: Using the Rochester Epidemiology Project, we retrospectively searched for the records of women aged 40-65 years who had a documented case of COVID-19 between March 12 and September 29, 2020. We further identified those who were perimenopausal or postmenopausal. The rates of emergency department visits, hospitalizations, and deaths were compared by hormone therapy use. Logistic regression models were used to assess the odds of the combined outcome based on hormone therapy use. Results: Among the 689 patients included in this study, the median age was 56 years, and 77.5% were White. Compared with patients currently using hormone therapy, those with past/never use of hormone therapy were significantly older, had more risk factors for severe COVID-19, and had a higher incidence of diabetes. A total of 102 emergency department visits/hospitalizations/deaths occurred among both groups. Participants with current hormone therapy use had similar rates and risk of emergency department/hospitalization/death outcomes as those without hormone therapy, even after adjusting for age and severe COVID-19 risk factors. Conclusions: Severe COVID-19 outcomes were not significantly different between women with current versus past/never use of hormone therapy. Our study adds to the data suggesting no harm with hormone therapy use in women with severe symptoms of COVID-19.

Objectives: To evaluate the performance of noninvasive, elastic scattering spectroscopy, algorithm-powered device (DermaSensor) to detect melanoma and basal and squamous cell cancers in the primary care setting. Patients & Methods: DERM-SUCCESS, a blinded, prospective, multicenter pivotal study, enrolled adult patients between August 17, 2020, and December 9, 2021, with lesions that their primary care physicians (PCPs) suspected of skin cancer at clinics in the US (n = 18) and Australia (n = 4). These lesions were assessed by PCPs and scanned with the DermaSensor device. Biopsy specimens were collected, and histopathologic analysis was performed by dermatopathologists. The diagnostic performance of the device, dermatopathologist discordance, and subgroup analyses of clinical interest were calculated. Results: Of the 1579 skin lesions enrolled, dermatopathologic analysis identified 224 (14.2%) cancers. Device sensitivity was 95.5% (95% CI, 91.7%-97.6%) overall and 96.3% (92.9%-98.4%) for patients in the FDA-approved age group 40 years and older (90.2% for melanoma, 97.8% for basal cell carcinoma, and 97.7% for squamous cell carcinoma). Device specificity was 20.7%. The negative predictive value was 96.6%, and the positive predictive value was 16.6% (NNB 6). The device misclassified as “ monitor ” rather than “ investigate further ” 4 keratinocyte carcinomas and 4 melanomas in patients aged 40 years or older (n = 8, 0.5% of lesions, 3.7% of cancers biopsied). Conclusions: The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer adjunctive diagnostic device with high sensitivity and NPV to help inform PCP decision-making about skin lesions suspicious for cancer that need further evaluation and those that may be monitored.

Background: Artificial intelligence (AI) platforms can potentially enhance clinical decision-making (CDM) in primary care settings. OpenEvidence (OE), an AI tool, draws from trusted sources to generate evidence-based medicine (EBM) recommendations to address clinical questions. However, its effectiveness in real-world primary care cases remains unknown. Objective: To evaluate the performance of OE in providing EBM recommendations for five common chronic conditions in primary care: hypertension, hyperlipidemia, diabetes mellitus type 2, depression, and obesity. Methods: Five patient cases were retrospectively analyzed. Physicians posed specific clinical questions, and OE responses were evaluated on clarity, relevance, evidence support, impact on CDM, and overall satisfaction. Four independent physicians provided ratings using a 0 to 4 scale. Results: OE provided accurate, evidence-based recommendations in all cases, aligning with physician plans. OE was scored on a scale of zero to four, where zero was very unclear, and four was very clear. Mean scores across cases were clarity (3.55 ± 0.60), relevance (3.75 ± 0.44), support (3.35 ± 0.49), and satisfaction (3.60 ± 0.60). However, the impact on CDM was limited (1.95 ± 1.05), as OE primarily reinforced rather than modified plans. Conclusion: OE was rated high in clarity, relevance, and evidence-based support, reinforcing physician decisions in common chronic conditions. While the impact on CDM was minimal due to the study’s retrospective nature, OE shows promise in augmenting the primary care physician. Prospective trials are needed to evaluate its utility in complex cases and multidisciplinary settings.

Abstract Introduction Tobacco use can adversely affect cancer treatment outcomes, yet routine assessment has not been fully incorporated into oncology clinical trials. In 2012, rates of tobacco use assessment in actively accruing National Cancer Institute (NCI) trials were < 30% at enrollment and < 5% during follow-up, prompting efforts by the NCI and major oncology associations to promote and standardize tobacco assessment in oncology research and practice (including development of the Cancer Patient Tobacco Use Questionnaire [C-TUQ]). This study was conducted to re-examine assessment patterns in 2022 (including utilization of the C-TUQ) and evaluate progress. Aims and Methods Protocols and forms from 144 actively accruing (as of December 2022) NCI National Clinical Trials Network (NCTN) trials were evaluated using a standardized coding instrument. Results Of 144 trials, 49.3% assessed tobacco use at enrollment (43.8% measured cigarettes, 14.8% e-cigarettes, and ≤ 12.5% other tobacco products). Approximately 20.8% used at least one C-TUQ question, but only 3.5% used all four core items. Few measured second-hand smoke exposure (3.5%) or quit interest (2.8%). At follow-up, 8.3% assessed any form of tobacco use. Assessment rates were higher in smoking-related cancer trials. Conclusions Almost half of the accruing trials did not measure any tobacco use and fewer used the C-TUQ. There was a ≥ 70% increase in tobacco use assessment at enrollment and follow-up compared to 2012, an improvement with room for further enhancement. Standardized tobacco use information enhances investigators’ ability to estimate cancer treatment efficacy, offer equitable cessation support, and accurately understand the impact of tobacco use on treatment outcomes. Implications In 2012, few (< 30%) cancer clinical trials evaluated tobacco use at enrollment and < 5% did so during follow-up, prompting efforts to promote and standardize tobacco assessment in oncology research and practice (including the development of the Cancer Patient Tobacco Use Questionnaire [C-TUQ]). The present study builds on this foundational paper and finds an overall increase in tobacco use assessment with room for improvement: 49.3% of trials in 2022 assessed tobacco use at enrollment and 8.3% did so during follow-up. About 20.8% used at least one C-TUQ question, highlighting that tobacco use assessment is not yet fully incorporated into oncology clinical trials.

Objective: Multicancer Detection (MCD) tests, such as the GRAIL Galleri, offer a novel approach to cancer screening by detecting cancer-specific methylation patterns in cell-free DNA through a single blood sample. This study evaluated an 18-month implementation of MCD testing in a tertiary ambulatory internal medicine clinic. Patients and Methods: Between June 2022 and November 2023, 2244 asymptomatic (without symptoms attributed to cancer) patients underwent MCD testing. The study focused on operational workflows, patient and physician education, and diagnostic follow-up of positive results. Standardized materials, including electronic health record (EHR) workflows, FAQs, and diagnostic pathways, were developed to facilitate implementation. Challenges included managing false positives, patient anxiety, costs, and ethical considerations. Results: Of the 2244 patients tested, 17 (0.76%) had positive results, and 15 underwent further diagnostic evaluation. Cancer was confirmed in 11 (73.3%) patients, including cases of breast, colon, esophageal, lymphoma, ovarian, and pancreatic cancers. Four patients had no identifiable malignancy despite comprehensive work-up. Conclusions: MCD testing is feasible in routine clinical workflows, with 73% of positive cases yielding cancer diagnoses. While promising, further research is required to assess long-term outcomes, cost-effectiveness, and optimal implementation strategies of cancer interception in broader healthcare settings.

Introduction: The Undiagnosed Mass Clinic (UMC) at our institution is a clinical and research program created to address gaps in the early diagnostic phase of the cancer care continuum for patients with potential malignant neoplasms. All patients referred to the UMC are invited to participate in the UMC registry, which tracks operational and clinical metrics while maintaining a repository of blood and tissue specimens for future research. Methods: We conducted a retrospective cohort study of the first 100 patients enrolled in the UMC registry. We analyzed patient demographics, final diagnoses, and the time from initial consultation to final diagnosis. Results: Most participants were White (86%), non-Hispanic (93%), and married (72%). The mean (SD) age was 64 (13.9) years. The final diagnoses of the masses were categorized as malignant/neoplastic with malignant potential (n = 53), benign (n = 36), or requiring diagnostic surveillance (n = 10). The mean (SD) time from initial consultation to final diagnosis of malignant/neoplastic with malignant potential masses significantly improved from 37.4 (36.6) days for the first 50 participants to 17.3 (19.7) days for the next 50 participants ( P = .006). Conclusions: These initial insights from the UMC registry will help direct future efforts to improve the care of patients with potential malignant neoplasms.

Objective: This study evaluated the feasibility and satisfaction of using a wearable brain activity sensing device for stress reduction among patients experiencing Long COVID (LC). Patients and Methods: Patients with LC (N = 45) were invited to participate in an open-label pilot study. Participants were asked to use a brain-sensing electroencephalogram (S-EEG) wearable device (Muse-S™) daily for 90 days and followed for an additional 90 days (180 days total participation). Study enrollment began June 28, 2022, and ended July 28, 2023. Results: Patients were predominantly female (82%), white (96%), and with an average age of 47.6 (±12.5) years. At the end of treatment (90 days), cognition, sleep, self-efficacy, and quality-of-life quality of life improved ( P < .001 to P = .04). In addition, stress and anxiety were significantly reduced ( P < .001). These significant changes persisted by end-of-study (180 days). For stress ( P = .023) and anxiety ( P = .033), a change from the baseline during follow-up was significantly associated with the amount of S-EEG usage. The end-of-study satisfaction survey indicated that patients were very satisfied with the S-EEG device, and 97% planned to continue using it. Conclusion: Results suggest that the S-EEG device improved cognition in LC, which is one of the main severe symptoms we see in our LC clinic. In addition, it helped reduce stress and anxiety. These findings have important clinical implications for LC patients using S-EEG as an adjunct to concurrent LC clinical care which includes pharmacotherapies.

Background More than 1 in 5 US adults live with mental illness. Novel therapies as complements to standard therapies are needed to improve patient well-being. Reiki is a biofield therapy that may improve well-being in mental health. Objective The primary aim of this study was to evaluate the feasibility of providing Reiki at a behavioral health clinic serving a low-income population. The secondary aim was to evaluate outcomes in terms of patients’ symptoms, emotions, and feelings before and after Reiki. Methods This was a mixed-methods, feasibility pilot study with a pre-post experimental design. Reiki was offered to adult outpatients at a community behavioral health center in Rochester, Minnesota. Patients with a stable mental health diagnosis seen between July 22, 2021, and May 18, 2023, completed surveys before and after the Reiki intervention and provided qualitative feedback. Patients were asked to report their ratings of pain, anxiety, fatigue, and feelings (eg, happy, calm) on 0- to 10-point numeric rating scales. Data were analyzed with Wilcoxon signed rank tests. Results Among 91 patients who completed a Reiki session during the study period, 74 (81%) were women. Major depressive disorder (71%), posttraumatic stress disorder (47%), and generalized anxiety disorder (43%) were the most common diagnoses. The study was feasible in terms of recruitment, retention, data quality, acceptability, and fidelity of the intervention. Patient ratings of pain, fatigue, anxiety, stress, sadness, and agitation were significantly lower, and ratings of happiness, energy levels, relaxation, and calmness were significantly higher after a single Reiki session. Conclusion The results of this study suggest that Reiki is feasible and could be fit into the flow of clinical care in an outpatient behavioral health clinic. It improved positive emotions and feelings and decreased negative measures. Implementing Reiki in clinical practice should be further explored to improve mental health and well-being.