Understanding the concept of trust and other factors related to COVID-19 vaccine intentions among Black/African American older adults prior to vaccine development.

Background: Black/African Americans are receiving COVID-19 vaccines at much lower rates than whites. However, research is still evolving that explains why these vaccination rates are lower. The aim of this study was to examine the effects of the pandemic among older Black/African Americans, with an emphasis on trust and vaccine intention prior to vaccine development. Methods: Data were collected between July and September 2020 from 8 virtual focus groups in Detroit, MI and San Francisco Bay Area, CA with 33 older African Americans and 11 caregivers of older African Americans with cognitive impairment, supplemented by one virtual meeting with the project's Community Advisory Board. Inductive/deductive content analysis was used to identify themes. Results: Five major themes influenced the intention to be vaccinated: uncertainty, systemic abandonment, decrease in trust, resistance to vaccines, and opportunities for vaccination. The last theme, opportunities for vaccination, emerged as a result of interaction with our CAB while collecting project data after the vaccines were available which provided additional insights about potential opportunities that would promote the uptake of COVID-19 vaccination among older Black/African Americans. The results also include application of the themes to a multi-layer framework for understanding precarity and the development of an Integrated Logic Model for a Public Health Crisis. Conclusions: These findings suggest that trust and culturally relevant information need to be addressed immediately to accelerate vaccine uptake among older Black/African Americans. New initiatives are needed to foster trust and address systemic abandonment from all institutions. In addition, culturally relevant public health campaigns about vaccine uptake are needed. Thus, systemic issues need immediate attention to reduce health disparities associated with COVID-19.

An Interview-Based Assessment of the Experience of Cognitive Impairment in Multiple Sclerosis: The Cognitive Assessment Interview (CAI).

Background: Cognitive impairment is a common feature of multiple sclerosis (MS). A semi-structured interview, including informant input, can characterize the experience of individuals living with MS and cognitive involvement. Objective: We administered the Cognitive Assessment Interview (CAI), a patient- and informant-based semi-structured interview, to characterize the experience of cognitive impairments in those living with MS. Methods: Trained raters administered the CAI to a sample of MS participants and their informants enrolled for a trial of cognitive remediation. Cognitive impairments on the CAI were characterized and compared to those captured by neuropsychological and self-report measures. Results: A total of n = 109 MS participants (mean age = 50.3 ± 12.2) and their available informants (n = 71) were interviewed. Participants reported experiencing processing speed (90/106, 85%), working memory (87/109, 80%), and learning and memory (79/109, 72%) problems most commonly. CAI-based ratings were moderately correlated with a self-report measure (Multiple Sclerosis Neuropsychological Screening Questionnaire, r s = 0.52, p < 0.001) and only mildly correlated with objective neuropsychological measures specific to executive functions (r s = 0.21, p = 0.029). For those with informant interviews, ratings were overall consistent, suggesting that the CAI is valid even in cases in which an informant is unavailable and the interview is conducted with the patient alone (as is often the case in clinical and research settings). Conclusions: The CAI provides a semi-structured interview to characterize the experience of cognitive impairment in MS, with findings representing real-world functioning, adding valuable information to both self-report measures and neuropsychological assessment.

Telerehabilitation benefits patients with multiple sclerosis in an urban setting.

INTRODUCTION: People living with multiple sclerosis (MS) often require rehabilitation to manage their symptoms. Telerehabilitation offers improved access to treatment options by reducing travel time and cost. Our telerehabilitation program pairs training exercises simultaneously with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. In the current study, we characterized the benefits of our remotely supervised tDCS (RS-tDCS) at-home telerehabilitation protocol in an urban sample of MS participants. METHODS: Participants with MS were recruited to complete a telerehabilitation trial using tDCS paired with cognitive rehabilitation at-home using remote supervision (RS-tDCS). Participant time and travel costs for study visits to our clinic in midtown New York City were calculated. RESULTS: Forty-four patients with MS (aged 18 to 71) with mild to severe neurologic disability (Expanded Disability Status Scale score median = 3.5, range: 0.0 to 8.0) completed the survey. Round-trip clinic attendance required 2.3 ± 2.3 h and US $27.04 ± 38.13 for out-of-pocket expenses. Participants rated difficulty of clinic attendance as moderately to significantly difficult (2.5 ± 1.3). Severity of neurologic disability accounted for the greatest variance in difficulty attending clinic (30%, p < 0.001). RS-tDCS had 95% treatment compliance and 93% of participants reported satisfaction with the at-home treatment. DISCUSSION: Attending clinic is associated with significant costs for patients with neurologic disorders, even in urban settings. Rehabilitation can be delivered at home and supervised in real-time via videoconference.

Hospital-Wide Medication Reconciliation Program: Error Identification, Cost-Effectiveness, and Detecting High-Risk Individuals on Admission.

BACKGROUND: Medication reconciliation (MR) on admission has potential to reduce negative patient outcomes. The objectives of this prospective observational study were to 1) measure the impact a hospital-wide MR program has on home medication error identification at hospital admission, 2) demonstrate cost-effectiveness of this program, and 3) identify risk factors placing individual patients at higher risk for medication discrepancies. METHODS: Technicians obtained medication histories on adult patients admitted to the hospital that managed their own medications. Frequency and type of medication errors were recorded. Cost avoidance estimations were determined based on expected adverse drug event rates. Logistic regression analysis was used to test for associations between medication errors and patient characteristics. Results were considered significant when p-value was less than 0.05. RESULTS: The study included 817 patients. Technicians recorded a mean of 6.1 medication discrepancies per patient (SD ± 0.4) and took 28.5 minutes (SD ± 1.2 minutes) to complete a medication history. Omission, commission, and dosing/frequency errors occurred in 82%, 59%, and 50% of medication histories, respectively. We estimated cost avoidance of $210.33 per patient with this program. Female gender, age, and high alert/risk medication use were linked to an increase in the likelihood of occurrence of a medication discrepancy. CONCLUSION: This study validated the ability of a pharmacy technician to identify errors, demonstrated economic cost-effectiveness, provided new data on time to obtain a BPMH, and further identified factors that contribute to the occurrence of medication discrepancies. Potentially harmful medication discrepancies were identified frequently on admission. With further research, it may be possible to identify those at highest risk for home medication discrepancies upon admission.

Cognitive impairment in pediatric-onset multiple sclerosis is detected by the Brief International Cognitive Assessment for Multiple Sclerosis and computerized cognitive testing.

BACKGROUND: Cognitive impairment is a common and troubling feature of pediatric-onset multiple sclerosis (POMS). Brief cognitive assessment in the outpatient setting can identify and longitudinally monitor cognitive involvement so that early intervention is possible. OBJECTIVES: The goal of this study was to measure the sensitivity of two cognitive assessment approaches that are brief, repeatable, and suitable for clinical practice and for multicenter investigation. METHODS: Participants with POMS ( n = 69) were consecutively evaluated as part of outpatient neurologic visits and compared to healthy control participants (HC, n = 66) using the Brief International Cognitive Assessment for MS (BICAMS) approach and timed information processing measures from Cogstate, a computer-based assessment. RESULTS: There was strong agreement in the detection rate of impairment between both assessments, with 26% for the BICAMS and 27% for Cogstate. Two of the Cogstate tasks were the most sensitive individual measures. CONCLUSION: Both the BICAMS and Cogstate timed processing measures offer practical, sensitive, and standardized approaches for cognitive screening assessment in POMS.

Out-of-Pocket Cost Is a Barrier to Therapeutic Drug Monitoring in Inflammatory Bowel Disease.

BACKGROUND: Therapeutic drug monitoring (TDM) is increasingly performed to optimize biologic therapy in inflammatory bowel disease (IBD). However, patients and physicians may be reluctant to perform TDM due to concerns related to potential out-of-pocket costs. AIMS: The aim of this study was to evaluate patient understanding and attitudes toward TDM in different clinical scenarios with and without potential out-of-pocket costs. METHODS: Adult IBD patients at a tertiary gastroenterology clinic were anonymously surveyed from March to September 2016 to assess their understanding of and willingness to undergo TDM in a variety of clinical scenarios, both with and without a potential out-of-pocket cost. Responses were analyzed for associations with changes in attitudes if out-of-pocket costs were involved. RESULTS: Of 118 completed surveys, 68.2% of patients were aware of or had previously undergone TDM. Patient willingness to undergo TDM was high both with and without potential out-of-pocket costs (70 and 98%, respectively); however, patients were significantly less willing with out-of-pocket cost (p < 0.01). Higher disease-related quality of life scores, as measured by the short inflammatory bowel disease questionnaire (SIBDQ), was significantly associated with an increased willingness to assume a potential out-of-pocket cost (p = 0.007). CONCLUSIONS: Overall, patients understand and are willing to undergo TDM in certain potentially beneficial clinical scenarios, however, are significantly less willing if paying out-of-pocket. A higher SIBDQ score was associated with an increase in willingness to undergo TDM when out-of-pocket cost was involved. Physicians should discuss TDM with their patients in order to make an informed and personalized treatment decision.

Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial.

Cognitive impairment affects more than half of all individuals living with multiple sclerosis (MS). We hypothesized that training at home with an adaptive online cognitive training program would have greater cognitive benefit than ordinary computer games in cognitively-impaired adults with MS. This was a double-blind, randomized, active-placebo-controlled trial. Participants with MS were recruited through Stony Brook Medicine and randomly assigned to either the adaptive cognitive remediation (ACR) program or active control of ordinary computer games for 60 hours over 12 weeks. Training was remotely-supervised and delivered through a study-provided laptop computer. A computer generated, blocked stratification table prepared by statistician provided the randomization schedule and condition was assigned by a study technician. The primary outcome, administered by study psychometrician, was measured by change in a neuropsychological composite measure from baseline to study end. An intent-to-treat analysis was employed and missing primary outcome values were imputed via Markov Chain Monte Carlo method. Participants in the ACR (n = 74) vs. active control (n = 61) training program had significantly greater improvement in the primary outcome of cognitive functioning (mean change in composite z score±SD: 0·25±0·45 vs. 0·09±0·37, p = 0·03, estimated difference = 0·16 with 95% CI: 0·02-0·30), despite greater training time in the active control condition (mean±SD:56·9 ± 34·6 vs. 37·7 ±23 ·8 hours played, p = 0·006). This study provides Class I evidence that adaptive, computer-based cognitive remediation accessed from home can improve cognitive functioning in MS. This telerehabilitation approach allowed for rapid recruitment and high compliance, and can be readily applied to other neurological conditions associated with cognitive dysfunction. TRIAL REGISTRATION: Clinicaltrials.gov NCT02141386.

Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures.

BACKGROUND: Flexible endoscopes are currently reused following cleaning and high-level disinfection. Contamination has been found on endoscopes, and infections have been linked to gastrointestinal, respiratory, and urologic endoscopes. METHODS: This longitudinal study involved visual inspections with a borescope, microbial cultures, and biochemical tests for protein and adenosine triphosphate to identify endoscopes in need of further cleaning or maintenance. Three assessments were conducted over a 7-month period. Control group endoscopes reprocessed using customary practices were compared with intervention group endoscopes subjected to more rigorous reprocessing. RESULTS: At final assessment, all endoscopes (N = 20) had visible irregularities. Researchers observed fluid (95%), discoloration, and debris in channels. Of 12 (60%) endoscopes with microbial growth, 4 had no growth until after 48 hours. There were no significant differences in culture results by study group, assessment period, or endoscope type. Similar proportions of control and intervention endoscopes (~20%) exceeded postcleaning biochemical test benchmarks. Adenosine triphosphate levels were higher for gastroscopes than colonoscopes (P = .014). Eighty-five percent of endoscopes required repair due to findings. CONCLUSIONS: More rigorous reprocessing was not consistently effective. Seven-day incubation allowed identification of slow-growing microbes. These findings bolster the need for routine visual inspection and cleaning verification tests recommended in new reprocessing guidelines.

Comprehensive assessment of 2009 pandemic influenza A (H1N1) virus drug susceptibility in vitro.

BACKGROUND: Antiviral drugs are an important option for managing infections caused by influenza viruses. This study assessed the drug susceptibility of 2009 pandemic influenza A (H1N1) viruses collected globally between April 2009 and January 2010. METHODS: Virus isolates were tested for adamantane susceptibility, using pyrosequencing to detect the S31N marker of adamantane resistance in the M2 protein and biological assays to assess viral replication in cell culture. To assess neuraminidase (NA) inhibitor (NAI) susceptibility, virus isolates were tested in chemiluminescent NA inhibition assays and by pyrosequencing to detect the H275Y (H274Y in N2 numbering) marker of oseltamivir resistance in the NA. RESULTS: With the exception of three, all viruses that were tested for adamantane susceptibility (n=3,362) were resistant to this class of drugs. All viruses tested for NAI susceptibility (n=3,359) were sensitive to two US Food and Drug Administration-approved NAIs, oseltamivir (mean ±sd 50% inhibitory concentration [IC(50)] 0.25 ±0.12 nM) and zanamivir (mean IC(50) 0.29 ±0.09 nM), except 23 (0.7%), which were resistant to oseltamivir, but sensitive to zanamivir. Oseltamivir-resistant viruses had the H275Y mutation in their NA and were detected in patients exposed to the drug through prophylaxis or treatment. NA activity of all viruses was inhibited by the NAIs peramivir, laninamivir (R-125489) and A-315675, except for H275Y variants, which exhibited approximately 100-fold reduction in peramivir susceptibility. CONCLUSIONS: This report provides data regarding antiviral susceptibility of 2009 pandemic influenza A (H1N1) surveillance viruses, the majority of which were resistant to adamantanes and sensitive to NAIs. These findings provide information essential for antiviral resistance monitoring and development of novel diagnostic tests for detecting influenza antiviral resistance.

A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI).

PURPOSE: Magnetic resonance imaging (MRI) in patients with Cardiovascular Implantable Electronic Devices (CIED) has not been approved by the Food and Drug Administration. Recent data suggests MRI as a relative rather than absolute contraindication in CIED patients. Recently, the American Heart Association has recommended defibrillation threshold testing (DFTT) in implantable cardioverter defibrillator (ICD) patients undergoing MRI. We evaluated the feasibility and safety of a protocol for MRI in CIED patients, incorporating the new recommendations on DFTT. METHODS: Consecutive patients with CIED undergoing MRI were included. The protocol consisted of continuous monitoring during imaging, device interrogation pre- and post-MRI, reprogramming of the pacemaker to an asynchronous mode in pacemaker-dependent (PMD) patients and a non-tracking/sensing mode for non-PMD patients. All tachyarrhythmia therapies were disabled. Devices were interrogated for lead impedance, battery life, pacing, and sensing thresholds. All patients with ICD underwent DFTT/defibrillator safety margin testing (DSMT) post-MRI. RESULTS: A total of 92 MRI's at 1.5 Tesla were performed in 38 patients. A total of 13 PMD patients, ten ICD patients, four cardiac resynchronization therapy with defibrillator (CRT-D) patients, and 11 non-PMD patients were scanned from four major manufacturers. No device circuitry damage, programming alterations, inappropriate shocks, failure to pace, or changes in sensing, pacing, or defibrillator thresholds were found on single or multiple MRI sessions. CONCLUSIONS: Our protocol for MRI in CIED patients appears safe, feasible, and reproducible. This is irrespective of the type of CIED, pacemaker dependancy or multiple 24-h scanning sessions. Our protocol addresses early detection of potential complications and establishes a response system for potential device-related complications. Our observation suggests that routine DFTT/DSMT post-MRI may not be necessary.

The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials.

BACKGROUND: Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian. METHODS: Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor. RESULTS: The responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89. CONCLUSION: The results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity.