Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis.

BACKGROUND: Successful translation of evidence-based exercise training interventions from research to clinical practice depends on the balance of treatment fidelity and adaptability when delivering the exercise program across settings. The current paper summarizes fidelity of study design, provider training, and intervention delivery strategies from best practice recommendations, and reports challenges experienced and adaptations instrumented by behavioral coaches delivering the multi-site Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis (STEP for MS) Trial. METHODS: Using a reflexive thematic analysis approach, open-ended survey questions were analyzed to explore experiences of behavioral coaches, transcripts from team meetings among behavioral coaches, and notes from audits of one-on-one sessions between behavioral coaches and participants. RESULTS: Themes related to the fidelity of study design and delivery of the STEP for MS Trial included adaptations to the intervention itself (e.g., completion of virtual supervised exercise sessions with behavioral coaches in place of face-to-face sessions during COVID-19 pandemic restrictions), modification of exercise equipment, and adjustments of program delivery. The adjustments of program delivery reported by behavioral coaches included increasing program fit, maintaining engagement, and addressing participant safety concerns; however, these adaptations did not jeopardize the content of the essential elements of the program model. CONCLUSIONS: The current paper demonstrates that when best practice recommendations are implemented, it is possible to address challenges to study design and evidence-based intervention delivery in ways that adaptations to overcome real-world obstacles can be accomplished without compromising fidelity.

The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study.

BACKGROUND: During spring and summer 2020, US states implemented COVID-19 pandemic restrictions, resulting in the closure of rehabilitation facilities and, with them, some of the clinical trials that were taking place. One such trial was the Supervised Versus Telerehabilitation Exercise Program for Multiple Sclerosis ("STEP for MS") comparative effectiveness multiple sclerosis (MS) exercise trial. Although 1 study arm was implemented via telerehabilitation, the comparative arm took place in rehabilitation facilities nationwide and was subsequently closed during this time frame. The experience of the STEP for MS participants provides insights into the impact of lockdown restrictions on exercise behavior by mode of exercise delivery (telerehabilitation vs conventional facility based). OBJECTIVE: This study sought to understand the impact of COVID-19 lockdown restrictions on exercise behavior among people with MS enrolled in an exercise trial at the time of the restrictions. METHODS: Semistructured phone and video interviews were conducted with a convenience sample of 8 participants representing both arms of the exercise trial. We applied reflexive thematic analysis to identify, analyze, and interpret common themes in the data. RESULTS: We identified 7 main themes and 2 different narratives describing the exercise experiences during lockdown restrictions. Although the telerehabilitation participants continued exercising without interruption, facility-based participants experienced a range of barriers that impeded their ability to exercise. In particular, the loss of perceived social support gained from exercising in a facility with exercise coaches and other people with MS eroded both the accountability and motivation to exercise. Aerobic exercises via walking were the most impacted, with participants pointing to the need for at-home treadmills. CONCLUSIONS: The unprecedented disruption of COVID-19 lockdown restrictions in spring and summer 2020 impacted the ability of facility-based STEP for MS exercise trial participants to exercise in adherence to the intervention protocol. By contrast, the participants in the telerehabilitation-delivered exercise arm continued exercising without interruption and reported positive impacts of the intervention during this time. Telerehabilitation exercise programs may hold promise for overcoming barriers to exercise for people with MS during COVID-19 lockdown restrictions, and potentially other lockdown scenarios, if the participation in telerehabilitation has already been established.

Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis.

BACKGROUND: We propose a Phase III trial that compares the effectiveness of an exercise training program delivered in a facility-based setting with direct, in-person supervision or a home-based setting with remote supervision via telerehabilitation for improving walking performance in persons with multiple sclerosis(MS) who have walking dysfunction and mobility disability. METHODS/DESIGN: The study was developed with stakeholder engagement and is a multi-site trial that follows a 2-stage, randomized choice design. The trial compares the effectiveness of a 16-week evidence-based, individualized exercise program delivered in a supervised, facility-based setting versus a remotely coached/guided, home-based setting using telerehabilitation in physically inactive and cognitively intact people with MS who have walking dysfunction and mobility disability(N = 500). The primary outcome is walking speed. The secondary outcomes are walking endurance, disability status, and patient-reported outcomes of physical activity, walking impairment, fatigue, and quality of life. The components of the exercise program itself are similar between the groups and follow the Guidelines for Exercise in MS protocol. This includes a program manual, exercise prescription, exercise equipment, social-cognitive theory materials including newsletters, logs, and calendars, and one-on-one behavioral coaching by exercise specialists with background in MS. The main difference between groups is the coaching approach and setting for delivering the exercise training program. The outcomes will be collected by treatment-blinded assessors at baseline(week 0), mid-intervention(week 8), post-intervention(week 16), and follow-up(week 52). DISCUSSION: The proposed study will provide evidence for the effectiveness of a novel, widely-scalable program for delivering exercise training in persons with MS who have walking dysfunction and mobility disability.

Comparing models of maternity care serving women at risk of poor birth outcomes in Washington, DC.

Low-income African American women in Washington, DC, exhibit some of the worst birth outcomes in the United States. The authors undertook a qualitative, comparative case study of three different models of maternity care delivery to low-income women at risk of poor birth outcomes in Washington. The key study objectives were (1) to describe the organization, delivery, and content of care of the three models of maternity care and (2) to analyze how the models of care might be improved to better serve this population efficiently and cost-effectively. Our results indicate that all three models vary distinctly in how they organize and deliver care and what composes the content of care. Further, findings suggest that pregnant low-income women require the allocation of additional and nontraditional maternity care resources such as prenatal group care and breastfeeding peer counselors. These nontraditional components of care help providers address underlying social risk factors that may be negatively affecting the health of pregnant women and their unborn children. While nontraditional maternity care models may provide greater value for money than traditional obstetric models, they face funding and sustainability challenges.

Improving coverage and access for immigrant Latino children: the Los Angeles healthy kids program.

A large number of California counties have recently taken bold steps to extend health insurance to all poor and near-poor children through county-based Children's Health Initiatives. One initiative, the Los Angeles Healthy Kids program, extends coverage to uninsured children in families with incomes below 300 percent of the federal poverty level who are ineligible for Medi-Cal (California Medicaid) and Healthy Families (its State Children's Health Insurance Program). A four-year evaluation of Healthy Kids finds that the program has improved access for more than 40,000, most of whom are immigrant Latino children, who have almost no access to employer coverage. However, sustaining this effective program has proved to be challenging.

Characterisation of GEA 3175 on human platelets; comparison with S-nitroso-N-acetyl-D,L-penicillamine.

By comparing the effect of two nitric oxide (NO)-containing compounds, we found that S-nitroso-N-acetyl-D,L-penicillamine (SNAP), but not GEA 3175 (1,2,3,4-Oxatriazolium,3-(3-chloro-2-metylphenyl)-5-[[(4-methylphenyl)sulfonyl]amino]-, hydroxide inner salt), released NO. Despite this, both drugs elevated cyclic guanosine 3',5'-monophosphate (cGMP) levels in human platelets. However, SNAP was more effective after short exposure times (5 and 20 s). The compounds also inhibited thrombin-induced rises in cytosolic Ca2+. Time studies revealed that the action of SNAP rapidly declined by increasing the length of incubation (from 5 s to 30 min). This desensibilisation phenomenon mainly involved the release of Ca2+ from intracellular stores. In comparison, GEA 3175-induced inhibition of cytosolic Ca2+ signalling was much more long-lasting. The soluble guanylyl cyclase (sGC) inhibitor 1H-[1,2,4]oxadiazolo[4,3-a]quinoxalin-1-one (ODQ) reversed the effect of GEA 3175 on cytosolic Ca2+. Consequently, this inhibition depends solely on the increase in cGMP. In summary, differences between GEA 3175 and SNAP were observed in NO releasing, cGMP elevating and Ca2+ suppressive properties.

The National Institute for Clinical Excellence and the RCM.

This article explains the role of the National Institute for Clinical Excellence (NICE) and how the RCM is involved in its operation.