scholarly journals COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial

10.2196/18415 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e18415 ◽  
Author(s):  
Byron Lai ◽  
Chia-Ying Chiu ◽  
Emily Pounds ◽  
Tracy Tracy ◽  
Tapan Mehta ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Blood Pressure ◽  
Alternative Medicine ◽  
Sensitivity Analyses ◽  
Complementary Alternative Medicine ◽  
Patient Centered ◽  
Study Results ◽  
The University ◽  
And Training

Background Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. Objective In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. Methods The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8” step, and a large-print 8” × 11” paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. Results The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. Conclusions This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. Trial Registration ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881 International Registered Report Identifier (IRRID) DERR1-10.2196/18415

scholarly journals COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Byron Lai ◽  
Chia-Ying Chiu ◽  
Emily Pounds ◽  
Tracy Tracy ◽  
Tapan Mehta ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Blood Pressure ◽  
Alternative Medicine ◽  
Sensitivity Analyses ◽  
Complementary Alternative Medicine ◽  
Patient Centered ◽  
Study Results ◽  
The University ◽  
And Training

BACKGROUND Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. OBJECTIVE In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. METHODS The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8” step, and a large-print 8” × 11” paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. RESULTS The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. CONCLUSIONS This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. CLINICALTRIAL ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18415

Abstract 356: Hypertension Management at the University of Michigan Student Run Free Clinic: Does it Meet National Guidelines?

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Lindsey Gakenheimer ◽  
Hari S Conjeevaram
Keyword(s):  
Blood Pressure ◽  
Salt Intake ◽  
Lifestyle Changes ◽  
Uncontrolled Hypertension ◽  
Diabetic Patients ◽  
University Of Michigan ◽  
Initial Visit ◽  
Free Clinic ◽  
The University

Purpose: The University of Michigan Student Run Free Clinic (UMSRFC) provides primary care to uninsured adults in Southeast Michigan. Optimal management of chronic conditions, such as hypertension, is one of the clinic’s primary goals. Our aim was to evaluate UMSRFC’s success in meeting the Centers of Medicare and Medicaid Service’s (CMS’s) goal of blood pressure (BP) within the recommended values for ≥63% of clinic patients diagnosed with hypertension. Methods: A retrospective chart review identified hypertensive patients with at least two UMSRFC visits between April 2012 and July 2013. Age, sex, ethnicity, body mass index, medications, blood pressure (BP), and comorbidities were extracted and stored in an online database. Patients were separated into two groups: those with controlled hypertension (≤140/90 mmHg for systolic/diastolic BP) at their most recent clinic date and those with uncontrolled hypertension (>140/90 mmHg for systolic/diastolic BP) at the most recent clinic visit. Results: Of 43 patients presenting with hypertension, 26 (60.5%) met inclusion criteria. The average age was 52.3 +/- 2.0 years, and 12 (46.2%) were male. The majority (17, 65.4%) of patients self-identified as Caucasian, and 24 (92.4%) were from Southeast Michigan. Follow-up BP was controlled for 17 (65.4%) patients. All 6 (23.1%) patients controlled at initial visit remained controlled at follow-up, and 15 (75%) of those uncontrolled at initial visit were controlled at follow-up. BP control among diabetic patients improved the most: from 1 (16.7%) to 5 (83.3%) (p=0.833) achieving control; statistical insignificance is likely due to sample size. Most patients reduced their BP with the addition of medications, but 2 (7.8%) achieved control with lifestyle changes (eg. reduced salt intake, increased exercise or improved home BP recording adherence) alone. Conclusions: UMSRFC has marginally exceeded CMS’s benchmark with 17 (65.4%) of patients with hypertension having a controlled blood pressure at follow-up. While this result demonstrates that a free clinic working with an uninsured population can provide quality care, UMSRFC will continue to work diligently toward the goal of controlled BP for 100% of patients with hypertension.

Depressive symptoms in a treated multiple sclerosis cohort

2003 ◽  
Vol 9 (6) ◽  
pp. 616-620 ◽  
Author(s):  
Scott B Patten ◽  
Shanika Fridhandler ◽  
Cynthia A Beck ◽  
Luanne M Metz
Keyword(s):  
Multiple Sclerosis ◽  
Depressive Symptoms ◽  
Interferon Beta ◽  
Rating Scale ◽  
Epidemiological Studies ◽  
Treatment Groups ◽  
Increased Risk ◽  
The University ◽  
Depression Ratings

Background: Recent side effect data from clinical trials of interferon beta in multiple sclerosis (MS) have failed to confirm that these medications are associated with an increased risk of depression. However, these studies have used highly selected samples and the results may not be generalizable to real world settings. Methods: C linical data on subjects from southern A lberta who have applied for, or are receiving, public reimbursement for MS treatment are maintained in a database at the University of C algary Multiple Sclerosis C linic. Depression ratings obtained using the C enter for Epidemiological Studies Depression Rating Scale (C ES-D) are included in this database. In the current analysis, these longitudinal data were used to determine whether depressive symptoms were associated with disease-modifying treatments. Results: A t baseline, ratings were available for 163 subjects. Those choosing interferon beta resembled those choosing glatiramer acetate in most respects. During follow-up, no differences were observed in the prevalence or incidence of depression and C ES-D scores were not found to differ between the treatment groups. Conclusions: The failure to identify higher rates of depression both in previous intervention studies and in the current observational study provides confirmation that these drugs are not substantially associated with the occurrence of depression.

scholarly journals Cardiovascular End Points and Mortality Are Not Closer Associated With Central Than Peripheral Pulsatile Blood Pressure Components

Hypertension ◽  
2020 ◽  
Vol 76 (2) ◽  
pp. 350-358 ◽  
Author(s):  
Qi-Fang Huang ◽  
Lucas S. Aparicio ◽  
Lutgarde Thijs ◽  
Fang-Fei Wei ◽  
Jesus D. Melgarejo ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Pulse Pressure ◽  
Total Mortality ◽  
Model Fit ◽  
Sensitivity Analyses ◽  
End Points ◽  
Hazard Ratios ◽  
Peripheral Pulse ◽  
Central Pulse Pressure

Pulsatile blood pressure (BP) confers cardiovascular risk. Whether associations of cardiovascular end points are tighter for central systolic BP (cSBP) than peripheral systolic BP (pSBP) or central pulse pressure (cPP) than peripheral pulse pressure (pPP) is uncertain. Among 5608 participants (54.1% women; mean age, 54.2 years) enrolled in nine studies, median follow-up was 4.1 years. cSBP and cPP, estimated tonometrically from the radial waveform, averaged 123.7 and 42.5 mm Hg, and pSBP and pPP 134.1 and 53.9 mm Hg. The primary composite cardiovascular end point occurred in 255 participants (4.5%). Across fourths of the cPP distribution, rates increased exponentially (4.1, 5.0, 7.3, and 22.0 per 1000 person-years) with comparable estimates for cSBP, pSBP, and pPP. The multivariable-adjusted hazard ratios, expressing the risk per 1-SD increment in BP, were 1.50 (95% CI, 1.33–1.70) for cSBP, 1.36 (95% CI, 1.19–1.54) for cPP, 1.49 (95% CI, 1.33–1.67) for pSBP, and 1.34 (95% CI, 1.19–1.51) for pPP ( P <0.001). Further adjustment of cSBP and cPP, respectively, for pSBP and pPP, and vice versa, removed the significance of all hazard ratios. Adding cSBP, cPP, pSBP, pPP to a base model including covariables increased the model fit ( P <0.001) with generalized R 2 increments ranging from 0.37% to 0.74% but adding a second BP to a model including already one did not. Analyses of the secondary end points, including total mortality (204 deaths), coronary end points (109) and strokes (89), and various sensitivity analyses produced consistent results. In conclusion, associations of the primary and secondary end points with SBP and pulse pressure were not stronger if BP was measured centrally compared with peripherally.

scholarly journals Possible Predisposing Factors for Late Intraocular Lens Dislocation After Routine Cataract Surgery

Medicina ◽  
2013 ◽  
Vol 49 (5) ◽  
pp. 37 ◽  
Author(s):  
Lina Krėpštė ◽  
Loreta Kuzmienė ◽  
Arūnas Miliauskas ◽  
Ingrida Janulevičienė
Keyword(s):  
Cataract Surgery ◽  
Intraocular Lens ◽  
Odds Ratio ◽  
University Hospital ◽  
Intraocular Lens Dislocation ◽  
Complicated Cataract ◽  
Study Results ◽  
The University ◽  
Iol Dislocation

Objective. The aim of this study was to evaluate possible risk factors for late intraocular lens (IOL) dislocation after routine cataract surgery. Material and Methods. A retrospective analysis of medical records of all the patients who were treated in the university hospital between 2011 and 2012 for late IOL dislocation requiring surgical management after routine cataract surgery was performed. In total, 58 patients (58 eyes) were included into the study. Results. The mean time between cataract surgery and late IOL dislocation was 67.8 months (SD, 34.9). A negative correlation was found between the patient age at cataract surgery and the time between cataract surgery and IOL dislocation (r=–0.29; P=0.042). Late in-the-bag dislocation occurred in 87.9% and late out-of-the-bag dislocation in 12.1% of the cases. Pseudoexfoliation was present in 56.9% and 42.9% of the eyes with in-the-bag and out-of-the-bag dislocation, respectively. The odds ratio for IOL dislocation within 43 months after complicated cataract surgery was 24.0 (95% confidence interval [95% CI] 4.5–127.4; P<0.001) and for in-the-bag IOL dislocation 24.9 (95% CI, 4.2–148.0; P<0.001). The odds ratio for in-the-bag IOL dislocation within 43 months after advanced cataract surgery was 18.8 (95% CI, 2.0–180.0; P=0.011). Moreover, in-the-bag IOL dislocation occurred earlier in the patients with past uveitis (P=0.020) or zonule laxity (P=0.037). Conclusions. Complicated cataract surgery increased the risk of both late in-the-bag and out-ofthe- bag IOL dislocation, and advanced cataract increased the risk of late in-the-bag IOL dislocation. The time to in-the-bag IOL dislocation shortens with pseudoexfoliation syndrome, advanced age, or past uveitis. These factors must be taken into account while planning a postoperative follow-up.

Overview of STEPPS

2016 ◽  
pp. 1-28
Author(s):  
Nancee S. Blum ◽  
Don St. John ◽  
Bruce Pfohl ◽  
Donald W. Black
Keyword(s):  
Group Treatment ◽  
Adjunctive Treatment ◽  
Common Language ◽  
University Of Iowa ◽  
Behavioral Skills ◽  
The University ◽  
User Friendly ◽  
Evidence Based Programs ◽  
And Training

This chapter provides an overview of Systems Training for Emotional Predictability and Problem Solving (STEPPS), a manualized, cognitive-behavioral, skills-based group treatment program, originally developed as an adjunctive treatment for outpatients with borderline personality disorder. STEPPS was developed at the University of Iowa in 1995 in response to patient and provider needs. A detailed manual was developed and training workshops are conducted nationally and internationally. The systems component is unique to the program and refers to providing the client’s support system, (i.e., family members, friends, and key professionals) with an understanding of the STEPPS approach, a common language to communicate clearly about BPD, and ways to reinforce the skills that patients are acquiring. The program has been implemented worldwide and is included in SAMSHA’s NREPP list of evidence-based programs. The program is user-friendly and easily learned and delivered by therapists. A follow-up program, STAIRWAYS, is also described.

Contribution of different relapse phenotypes to disability in multiple sclerosis

2016 ◽  
Vol 23 (2) ◽  
pp. 266-276 ◽  
Author(s):  
Tamasine Stewart ◽  
Tim Spelman ◽  
Eva Havrdova ◽  
Dana Horakova ◽  
Maria Trojano ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Functional System ◽  
Sensitivity Analyses ◽  
Linear Regression Models ◽  
Differential Impact ◽  
Pronounced Increase ◽  
Disease Modifying Therapy ◽  
Disability Status ◽  
Important Objective

Objective: This study evaluated the effect of relapse phenotype on disability accumulation in multiple sclerosis. Methods: Analysis of prospectively collected data was conducted in 19,504 patients with relapse-onset multiple sclerosis and minimum 1-year prospective follow-up from the MSBase cohort study. Multivariable linear regression models assessed associations between relapse incidence, phenotype and changes in disability (quantified with Expanded Disability Status Scale and its Functional System scores). Sensitivity analyses were conducted. Results: In 34,858 relapses recorded during 136,462 patient-years (median follow-up 5.9 years), higher relapse incidence was associated with greater disability accumulation (β = 0.16, p < 0.001). Relapses of all phenotypes promoted disability accumulation, with the most pronounced increase associated with pyramidal (β = 0.27 (0.25–0.29)), cerebellar (β = 0.35 (0.30–0.39)) and bowel/bladder (β = 0.42 (0.35–0.49)) phenotypes (mean (95% confidence interval)). Higher incidence of each relapse phenotype was associated with an increase in disability in the corresponding neurological domain, as well as anatomically related domains. Conclusion: Relapses are associated with accumulation of neurological disability. Relapses in pyramidal, cerebellar and bowel/bladder systems have the greatest association with disability change. Therefore, prevention of these relapses is an important objective of disease-modifying therapy. The differential impact of relapse phenotypes on disability outcomes could influence management of treatment failure in multiple sclerosis.

scholarly journals Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results

2021 ◽  
pp. 135245852110379
Author(s):  
Ralf Gold ◽  
Douglas L Arnold ◽  
Amit Bar-Or ◽  
Robert J Fox ◽  
Ludwig Kappos ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Dimethyl Fumarate ◽  
Phase Iii ◽  
Study Results ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background: Dimethyl fumarate (DMF) demonstrated favorable benefit–risk in relapsing-remitting multiple sclerosis (RRMS) patients in phase-III DEFINE and CONFIRM trials, and ENDORSE extension. Objective: The main aim of this study is assessing DMF safety/efficacy up to 13 years in ENDORSE. Methods: Randomized patients received DMF 240 mg twice daily or placebo (PBO; Years 0–2), then DMF (Years 3–10; continuous DMF/DMF or PBO/DMF); maximum follow-up (combined studies), 13 years. Results: By January 2020, 1736 patients enrolled/dosed in ENDORSE (median follow-up 8.76 years (ENDORSE range: 0.04–10.98) in DEFINE/CONFIRM and ENDORSE); 52% treated in ENDORSE for ⩾6 years. Overall, 551 (32%) patients experienced serious adverse events (mostly multiple sclerosis (MS) relapse or fall; one progressive multifocal leukoencephalopathy); 243 (14%) discontinued treatment due to adverse events (4% gastrointestinal (GI) disorders). Rare opportunistic infections, malignancies, and serious herpes zoster occurred, irrespective of lymphocyte count. For DMF/DMF ( n = 501), overall annualized relapse rate (ARR) remained low (0.143 (95% confidence interval (CI), 0.120–0.169)), while for PBO/DMF ( n = 249), ARR decreased after initiating DMF and remained low throughout (ARR 0–2 years, 0.330 (95% CI, 0.266–0.408); overall ARR (ENDORSE, 0.151 (95% CI, 0.118–0.194)). Over 10 years, 72% DMF/DMF and 73% PBO/DMF had no 24-week confirmed disability worsening. Conclusion: Sustained DMF safety/efficacy was observed in patients followed up to 13 years, supporting DMF’s positive benefit/risk profile for long-term RRMS treatment.

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