Introducing Virtual Shared Medical Appointments as a Novel Treatment Platform for Functional Movement Disorders.

The landscape of medical care has rapidly evolved with technological advancements, particularly through the widespread adoption of virtual appointments catalyzed by the COVID-19 pandemic. This shift has transcended geographical barriers, enhancing access for underserved populations and those with disabilities to specialized healthcare providers. A notable development stemming from this trend is the emergence of virtual shared medical appointments (VSMAs), which integrate group-based education with telemedicine technology. While VSMAs have demonstrated efficacy in conditions such as obesity, diabetes, and neurological disorders, their effectiveness in managing Functional Movement Disorders (FMD) is currently under investigation. FMDs pose unique challenges in diagnosis and acceptance, with high rates of misdiagnosis and treatment delays. VSMAs offer a promising solution by providing educational modules and fostering peer support among patients with similar diagnoses. At the Cleveland Clinic Center for Neurological Restoration, VSMAs have been embraced to enhance care standards for FMD patients. The program facilitates educational sessions and follow-up meetings to improve treatment adherence and psychological well-being. Early outcomes indicate increased patient acceptance and engagement, with significant program growth observed. Ongoing research aims to evaluate stakeholder perspectives and refine session content to further reduce stigma and the healthcare burden associated with FMDs.

Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences.

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices.

Sustained improvements in pain, mood, function and opioid use post interdisciplinary pain rehabilitation in patients weaned from high and low dose chronic opioid therapy.

Increased prescribing of opioids for chronic noncancer pain is associated with significant social costs, including overdose and addiction. In this context, there is interest in interdisciplinary chronic pain rehabilitation programs focusing on self-management and minimizing opioid use. This study examined outcomes of patients weaned from opioids in an ICPRP from 2007 to 2012. Participants included 413 patients on high dose chronic opioid therapy (COT; >100 mg), 528 on low dose COT, and 516 not on opioids (NO). Outcomes were assessed at discharge, 6, and 12 months posttreatment through self-report and chart review. One thousand one hundred ninety-four participants completed treatment (81.95%); 86.74% of those on opioids were weaned. High doses were less likely to complete (78.45%) than NO participants (85.27%; P < 0.05). Results showed immediate (P < 0.01) and sustained improvements (P < 0.05) in pain severity, depression, anxiety, and functional impairment with no group differences. Effect sizes ranged from medium to large (Cohen d values 0.57-1.96). Longitudinal medication use data were available for 319 no dose and 417 weaned participants; opioid resumption rates were 10.51% and 30.70% respectively. There were no differences in resumption between the high dose and low dose groups. Logistic regression analyses determined that opioid dose predicted neither treatment completion nor opioid resumption. Anxiety predicted completion, and functional impairment predicted opioid resumption within 1 year of discharge. Results suggest that patients on COT can be successfully weaned with long-term benefits in pain, mood, and function. Targeting anxiety and functional restoration may increase success rates.

Relationships of race and socioeconomic status to postpartum depressive symptoms in rural African American and non-Hispanic white women.

This study examines the potential racial disparity in postpartum depression (PPD) symptoms among a cohort of non-Hispanic white and African American women after taking into consideration the influence of socioeconomic status (SES). Participants (N = 299) were recruited from maternity clinics serving rural counties, with oversampling of low SES and African Americans. The Edinburgh Postnatal Depression Scale (EPDS) was administered 1 and 6 months postpartum, and subjective SES scale at 6 months postpartum. Demographic information was collected during enrollment and 1 month postpartum, with updates at 6 months postpartum. Separate logistic regressions were conducted for 1 and 6 month time points for minor-major PPD (EPDS ≥ 10) and major PPD (EPDS > 12); with marital status, poverty, education, subjective SES, and race predictors entered in block sequence. After including all other predictors, race was not a significant predictor of minor-major or major PPD at 1 or 6 months postpartum. Subjective SES was the most consistent predictor of PPD, being significantly associated with minor-major PPD and major PPD at 6 months postpartum, with higher subjective SES indicating lower odds of PPD, even after accounting for all other predictors. This study shows that significant racial disparities were not observed for minor-major or major PPD criteria at 1 or 6 months postpartum. The most consistent and significant predictor of PPD was subjective SES. Implications of these findings for future research, as well as PPD screening and intervention are discussed.

A randomized phase II feasibility trial of BMS-275291 in patients with early stage breast cancer.

PURPOSE: This pilot trial was performed to evaluate the safety, pharmacokinetics and feasibility of incorporating BMS-275291, a matrix metalloproteinase inhibitor (MMPI), into adjuvant breast cancer therapy. EXPERIMENTAL DESIGN: Patients with stage I (T1c)-IIIA breast cancer were eligible if planned adjuvant therapy consisted of either tamoxifen alone, doxorubicin + cyclophosphamide every 21 days for four cycles (AC), or AC followed by paclitaxel every 21 days for 4 cycles (AC>T). Patients were stratified by planned adjuvant therapy and randomized (2:1 ratio) to BMS-275291 (1200 mg/day) or matched placebo for 1 year. RESULTS: Seventy-two patients were recruited from March 2001 to July 2002. Grade >or=2 musculoskeletal toxicity, generally reversible arthralgia, was reported by 36.2% of patients receiving BMS-275291 compared with 16.7% of patients receiving placebo; difference = 19.5% (95% confidence interval: -0.06, 0.44; P = NS). Two patients receiving BMS-275291 developed palpable nodules along tendons. Grade >or=3 rash was reported by 8.5% of patients receiving BMS-275291 compared with 4.2% of patients receiving placebo; difference = 4.3% (95% confidence interval: -0.18, 0.3; P = NS). Overall, 33% of BMS-275291 patients and 21% of placebo patients discontinued treatment due to adverse events. BMS-275291 trough levels tended to decrease over time; 9 of 47 (19%) had >or=50% of trough concentrations > 124 ng/ml (IC(90) for matrix metalloproteinase-9). CONCLUSIONS: The pattern of arthralgia in BMS-275291-treated patients was consistent with matrix metalloproteinase inhibitor toxicity. Although the differential incidence of arthralgia did not reach statistical significance, the trial was terminated. An adjuvant trial in this patient population is not feasible.