It Takes a Village: An Interdisciplinary Approach to Preparing Internal Medicine Residents to Care for Patients at the Intersection of Women's Health, Gender-Affirming Care, and Health Disparities.

Objective: To create an interdisciplinary curriculum to teach key topics at the intersection of women's health, gender-affirming care, and health disparities to internal medicine (IM) residents. Materials and Methods: A core team of faculty from IM, Obstetrics and Gynecology, and Surgery partnered with faculty and fellows from other disciplines and with community experts to design and deliver the curriculum. The resulting curriculum consisted of themed half-day modules, each consisting of three to four inter-related topics, updated and repeated on an ∼3-year cycle. Health equity was a focus of all topics. Module delivery used diverse interactive learning strategies. Modules have been presented to ∼175 residents annually, beginning in 2015. To assess the curriculum, we used formative evaluation methods, using primarily anonymous, electronic surveys, and collected quantitative and qualitative data. Most surveys assessed resident learning by quantifying residents' self-reported comfort with skills taught in the module pre- and postsession. Results: Of 131 residents who completed an evaluation in 2022/23, 121 (90%) "somewhat" or "strongly" agreed with their readiness to perform a range of skills taught in the module. In all previous years where pre- and postsurveys were used to evaluate modules, we observed a consistent meaningful increase in the proportion of residents reporting high levels of comfort with the material. Residents particularly valued interactive teaching methods, and direct learning from community members and peers. Conclusion: Our interdisciplinary curriculum was feasible, valued by trainees, and increased resident learning. The curriculum provides a template to address equity issues across a spectrum of women's and gender-affirming care conditions that can be used by other institutions in implementing similar curricula.

Serum Neutralizing Antibody Titers 12 Months After Coronavirus Disease 2019 Messenger RNA Vaccination: Correlation to Clinical Variables in an Adult, US Population.

BACKGROUND: We studied whether comorbid conditions affect strength and duration of immune responses after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA vaccination in a US-based, adult population. METHODS: Sera (before and after BNT162b2 vaccination) were tested serially up to 12 months after 2 doses of vaccine for SARS-CoV-2-anti-Spike neutralizing capacity by pseudotyping assay in 124 individuals; neutralizing titers were correlated to clinical variables with multivariate regression. Postbooster (third dose) effect was measured at 1 and 3 months in 72 and 88 subjects, respectively. RESULTS: After completion of primary vaccine series, neutralizing antibody half maximal inhibitory concentration (IC50) values were high at 1 month (14-fold increase from prevaccination), declined at 6 months (3.3-fold increase), and increased at 1 month postbooster (41.5-fold increase). Three months postbooster, IC50 decreased in coronavirus disease (COVID)-naïve individuals (18-fold increase) and increased in prior COVID 2019 (COVID-19+) individuals (132-fold increase). Age >65 years (ß = -0.94, P = .001) and malignancy (ß = -0.88, P = .002) reduced strength of response at 1 month. Both neutralization strength and durability at 6 months, respectively, were negatively affected by end-stage renal disease ([ß = -1.10, P = .004]; [ß = -0.66, P = .014]), diabetes mellitus ([ß = -0.57, P = .032]; [ß = -0.44, P = .028]), and systemic steroid use ([ß = -0.066, P = .032]; [ß = -0.55, P = .037]). Postbooster IC50 was robust against WA-1 and B.1.617.2. Postbooster neutralization increased with prior COVID-19 (ß = 2.9, P < .0001), and malignancy reduced neutralization response (ß = -0.68, P = .03), regardless of infection status. CONCLUSIONS: Multiple clinical factors affect the strength and duration of neutralization response after primary series vaccination, but not the postbooster dose strength. Malignancy was associated with lower booster-dose response regardless of prior COVID infection, suggesting a need for clinically guided vaccine regimens.

Longitudinal investigation of the factor structure of the Parkinson's disease activities of daily living, interference and dependence instrument.

The Parkinson's Disease Activities of Daily Living, Interference, and Dependence Instrument© (PD-AID) is a patient-reported outcome (PRO) instrument, recently developed to assess the clinical benefit of Parkinson's Disease (PD) treatment. The PD-AID consists of morning and evening assessments, administered daily. To benefit from the full set of the repeated observations over time, analytic approaches that account for both within- and between-individual variability are required. The current study aimed to employ the advantages of exploratory Multilevel Factor Analysis (MFA) on data collected from 93 participants with moderate to advanced PD, currently using and responding to Levodopa (L-Dopa), who completed the PD-AID twice daily as part of a prospective, non-intervention, observational study for ~28 days. Average daily completion rates were comparable for the Morning and the Evening PD-AID (78% and 74%, respectively). The intraclass correlation coefficients for the Morning and Evening PD-AID items were in the range of 0.70-0.90, with an average of 0.81 for the Morning PD-AID items and 0.83 for the Evening PD-AID items, suggesting that most variability (81%-83%) in responses was due to between-individual variability. For the Morning PD-AID, one factor (including nine out of 10 Morning PD-AID items) emerged at the between-individual level and four factors (core physical actions, basic self-care activities, feeding, and interference & dependence) at the within-individual level. For the Evening PD-AID, there were four between-individual factors (basic activities of daily living ADLs, life interference, impact on planning, and emotional consequences) and five within-individual factors (basic ADLs, toileting, life interference, medication planning, and emotional impact). The factors had high reliability.

Cessation of group battlefield acupuncture visits due to COVID-19: a pilot study.

BACKGROUND: Prior to the COVID-19 pandemic, battlefield acupuncture (BFA) was offered to veterans with chronic pain in multidisciplinary group visits. OBJECTIVE: We aimed to assess the impact of cessation of BFA due to COVID-19 and to determine the utility of different aspects of the group visits for chronic pain management. METHODS: Participants who had attended at least three BFA group visits completed questionnaires assessing the impact of treatment interruption on pain, overall function and desire to resume treatment. RESULTS: Thirty-nine veterans were surveyed; 49% responded to the questionnaire. Ninety percent (17/19) agreed that BFA was an important part of pain management and that their pain had worsened after treatment interruption. Seventy-four percent (14/19) responded that they were taking more pain medications since BFA had ended. Ninety-five percent (18/19) responded that BFA improved daily function; 79% (15/19) agreed that BFA improved their sleep. Ninety-five percent (18/19) were interested in resuming BFA. Camaraderie was mentioned as the most helpful aspect of the group by 8/19 (42%) of participants. Participation of health psychology and nutrition were each mentioned as a most helpful aspect of the group by 5/19 (26%) of participants. CONCLUSION: Our results suggest that participants may have believed that BFA, camaraderie, and input from nutrition and health psychology services were important contributors to their pain control. The results also suggest that veterans may have suffered worsening pain, used more pain medications, and had worsening quality of sleep and daily function during the COVID-related clinic disruption, and that they were interested in resumption of the program.

Clinical Variables Correlate with Serum Neutralizing Antibody Titers after COVID-19 mRNA Vaccination in an Adult, US-based Population.

Background: We studied whether comorbid conditions impact strength and duration of immune responses after SARS-CoV-2 mRNA vaccination in a US-based, adult population. Methods: Sera (pre-and-post-BNT162b2 vaccination) were tested serially up to 12 months after two doses of vaccine for SARS-CoV-2-anti-Spike neutralizing capacity by pseudotyping assay in 124 individuals; neutralizing titers were correlated to clinical variables with multivariate regression. Post-booster (third dose) effect was measured at 1 and 3 months in 72 and 88 subjects respectively. Results: After completion of primary vaccine series, neutralizing antibody IC50 values were high at one month (14-fold increase from pre-vaccination), declined at six months (3.3-fold increase), and increased at one month post-booster (41.5-fold increase). Three months post-booster, IC50 decreased in COVID-naïve individuals (18-fold increase) and increased in prior COVID-19+ individuals (132-fold increase). Age >65 years (ß=-0.94, p=0.001) and malignancy (ß=-0.88, p=0.002) reduced strength of response at 1 month. Both strength and durability of response at 6 months, respectively, were negatively impacted by end-stage renal disease [(ß=-1.10, p=0.004); (ß=-0.66, p=0.014)], diabetes mellitus [(ß=-0.57, p=0.032); (ß=-0.44, p=0.028)], and systemic steroid use [(ß=-0.066, p=0.032); (ß=-0.55, p=0.037)]. Post-booster IC50 was robust against WA-1 and B.1.617.2, but the immune response decreased with malignancy (ß =-0.68, p=0.03) and increased with prior COVID-19 (p-value < 0.0001). Conclusion: Multiple clinical factors impact the strength and duration of neutralization response post-primary series vaccination, but not the post-booster dose strength. Prior COVID-19 infection enhances the booster-dose response except in individuals with malignancy, suggesting a need for clinically guiding vaccine dosing regimens. Summary: Multiple clinical factors impact the strength and duration of neutralization response post-primary series vaccination. All subjects, irrespective of prior COVID infection, benefited from a third dose. Malignancy decreased response following third dose, suggesting the importance of clinically guided vaccine regimens.

Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials.

Monitoring the quality of clinical trial efficacy outcome data has received increased attention in the past decade, with regulatory guidance encouraging it to be conducted proactively, and remotely. However, the methods utilized to develop and implement risk-based data monitoring (RBDM) programs vary, and there is a dearth of published material to guide these processes in the context of central nervous system (CNS) trials. We reviewed regulatory guidance published within the past 6 years, generic white papers, and studies applying RBDM to data from CNS clinical trials. Methodologic considerations and system requirements necessary to establish an effective, real-time risk-based monitoring platform in CNS trials are presented. Key RBDM terms are defined in the context of CNS trial data, such as "critical data," "risk indicators," "noninformative data," and "mitigation of risk." Additionally, potential benefits of, and challenges associated with implementation of data quality monitoring are highlighted. Application of methodological and system requirement considerations to real-time monitoring of clinical ratings in CNS trials has the potential to minimize risk and enhance the quality of clinical trial data.

Norms for healthy adults aged 18-87 years for the Cognitive Drug Research System: An automated set of tests of attention, information processing and memory for use in clinical trials.

The Cognitive Drug Research (CDR) System is a set of nine computerized tests of attention, information processing, working memory, executive control and episodic memory which was designed for repeated assessments in research projects. The CDR System has been used extensively in clinical trials involving healthy volunteers for over 30 years, and a database of 7751 individuals aged 18-87 years has been accumulated for pre-treatment data from these studies. This database has been analysed, and the relationships between the various scores with factors, including age, gender and years of full-time education, have been identified. These analyses are reported in this paper, along with tables of norms for the various key measures from the core tasks stratified by age and gender. These norms can be used for a variety of purposes, including the determination of eligibility for participation in clinical trials and the everyday relevance of research findings from the system. In addition, these norms provide valuable information on gender differences and the effects of normal ageing on major aspects of human cognitive function.

Establishing Equivalence of Electronic Clinician-Reported Outcome Measures.

BACKGROUND: Electronic administration of clinician-reported outcomes (eClinROs) has advantages over paper-based methods, but the mode of administration change has the potential to affect the validity of the scale. The literature on migration of patient-reported outcomes (PROs) suggests that there are different levels of modification, which necessitate different approaches to demonstrating mode equivalence. However, little has been written on the migration of ClinROs to electronic administration. METHODS: We propose a method of comparing paper and electronic versions of scales that includes a comparison based on content and a comparison based on format. The determination of whether the eClinRO has undergone minor, moderate, or substantial modification will drive the necessary studies required for validation. RESULTS: The unique characteristics of ClinROs suggest 2 additional types of modifications, including functionality adaptation and adaptation of instructions. CONCLUSIONS: In many respects, the migration of a ClinRO to electronic administration is similar to that of a PRO. This article has explored the ways in which there might be special considerations for ClinROs that have not been elaborated for PROs.