21 research outputs found
Results of a Feasibility Randomized Controlled Trial (RCT) of the Toolkit for Optimal Recovery (TOR): A Live Video Program to Prevent Chronic Pain in At-Risk Adults with Orthopedic Injuries
Background: Orthopedic injuries are the leading cause of hospital admissions in the USA, and many of these patients transition into chronic pain. Currently, there are no evidence-based interventions targeting prevention of chronic pain in patients with orthopedic injuries. We iteratively developed a four-session intervention âThe Toolkit for Optimal Recoveryâ (TOR) which we plan to subsequently test for efficacy in a phase III hybrid efficacy-effectiveness multi-site clinical trial. In order to prevent methodological weaknesses in the subsequent trial, we conducted a feasibility pilot to evaluate the TOR delivered via secure live video versus usual care (UC) in patients with orthopedic injuries from an urban, level I trauma clinic, who screen in as at risk for chronic pain and disability. We tested the feasibility of recruitment, acceptability of screening, and randomization methods; acceptability of the intervention, treatment adherence, and treatment fidelity; satisfaction with the intervention; feasibility of the assessment process at all time points; acceptability of outcome measures for the definitive trial; and within-treatment effect sizes.
Methods: We aimed to recruit 50â60 participants, randomize, and retain them for ~â4âmonths. Assessments were done electronically via REDCap at baseline, post-intervention (approximately 5âweeks after baseline), and 3âmonths later. We followed procedures we intend to implement in the full-scale hybrid efficacy-effectiveness trial.
Results: We recruited 54 participants and found that randomization and data collection procedures were generally acceptable. The majority of participants were white, educated, and employed. Warm hand-off referrals were more effective than research assistants directly approaching patients for participation without their providersâ engagement. Feasibility of recruitment, acceptability of screening, and randomization were good. Satisfaction with the program, adherence to treatment sessions, and treatment fidelity were all high. There were no technical issues associated with the live video delivery of the TOR. There was minimal missing data and outcome measures were deemed appropriate. Effect sizes for improvement after participation in TOR were moderate to large. There were many lessons learned for future trials.
Conclusions: This study provided evidence of the feasibility of the planned hybrid efficacy-effectiveness trial design when implemented at our home institution. Establishing feasibility of the intervention and study procedures at other trauma centers with more diverse patient populations and different clinical practices is required before a multi-site phase III efficacy-effectiveness trial.
Trial registration: ClinicalTrials.gov ID: NCT03405610. Registered on January 28, 2018âretrospectively registered
Small-Scale Structure in the SDSS and LCDM: Isolated L* Galaxies with Bright Satellites
We use a volume-limited spectroscopic sample of isolated galaxies in the
Sloan Digital Sky Survey (SDSS) to investigate the frequency and radial
distribution of luminous (M_r <~ -18.3) satellites like the Large Magellanic
Cloud (LMC) around ~L* Milky Way analogs and compare our results
object-by-object to LCDM predictions based on abundance matching in
simulations. We show that 12% of Milky Way-like galaxies host an LMC-like
satellite within 75 kpc (projected), and 42 % within 250 kpc (projected). This
implies ~10% have a satellite within the distance of the LMC, and ~40% of L*
galaxies host a bright satellite within the virialized extent of their dark
matter halos. Remarkably, the simulation reproduces the observed frequency,
radial dependence, velocity distribution, and luminosity function of observed
secondaries exceptionally well, suggesting that LCDM provides an accurate
reproduction of the observed Universe to galaxies as faint as L~10^9 Lsun on
~50 kpc scales. When stacked, the observed projected pairwise velocity
dispersion of these satellites is sigma~160 km/s, in agreement with
abundance-matching expectations for their host halo masses. Finally, bright
satellites around L* primaries are significantly redder than typical galaxies
in their luminosity range, indicating that environmental quenching is operating
within galaxy-size dark matter halos that typically contain only a single
bright satellite. This redness trend is in stark contrast to the Milky Way's
LMC, which is unusually blue even for a field galaxy. We suggest that the LMC's
discrepant color might be further evidence that it is undergoing a triggered
star-formation event upon first infall.Comment: 14 pages, 11 figures; accepted to Ap
Mild and Chemoselective Carboxylic Acid Reduction Promoted by Borane Catalysis
Although considerable advances have been made in developing chemoselective transformations of ubiquitous carboxylic acid groups, many challenges still exist. For instance, their selective reduction is problematic if both more nucleophilic and more electrophilic groups are present in the starting material. Here, we address this problem with a simple and mild protocol using benchâstable reagents at ambient temperatures. This platform is able to tolerate a diverse range of functionality, leaving ketones, esters, nitroâgroups, olefins, nitriles and amides untouched. A combination of experimental and computational mechanistic experiments demonstrate that this reaction proceeds via hidden borane catalysis with small quantities of in situ generated BH(3) playing a key role in the exquisite selectivity that is observed
Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries
Abstract Background Orthopedic injuries are the leading cause of hospital admissions in the USA, and many of these patients transition into chronic pain. Currently, there are no evidence-based interventions targeting prevention of chronic pain in patients with orthopedic injuries. We iteratively developed a four-session intervention âThe Toolkit for Optimal Recoveryâ (TOR) which we plan to subsequently test for efficacy in a phase III hybrid efficacy-effectiveness multi-site clinical trial. In order to prevent methodological weaknesses in the subsequent trial, we conducted a feasibility pilot to evaluate the TOR delivered via secure live video versus usual care (UC) in patients with orthopedic injuries from an urban, level I trauma clinic, who screen in as at risk for chronic pain and disability. We tested the feasibility of recruitment, acceptability of screening, and randomization methods; acceptability of the intervention, treatment adherence, and treatment fidelity; satisfaction with the intervention; feasibility of the assessment process at all time points; acceptability of outcome measures for the definitive trial; and within-treatment effect sizes. Methods We aimed to recruit 50â60 participants, randomize, and retain them for ~â4âmonths. Assessments were done electronically via REDCap at baseline, post-intervention (approximately 5âweeks after baseline), and 3âmonths later. We followed procedures we intend to implement in the full-scale hybrid efficacy-effectiveness trial. Results We recruited 54 participants and found that randomization and data collection procedures were generally acceptable. The majority of participants were white, educated, and employed. Warm hand-off referrals were more effective than research assistants directly approaching patients for participation without their providersâ engagement. Feasibility of recruitment, acceptability of screening, and randomization were good. Satisfaction with the program, adherence to treatment sessions, and treatment fidelity were all high. There were no technical issues associated with the live video delivery of the TOR. There was minimal missing data and outcome measures were deemed appropriate. Effect sizes for improvement after participation in TOR were moderate to large. There were many lessons learned for future trials. Conclusions This study provided evidence of the feasibility of the planned hybrid efficacy-effectiveness trial design when implemented at our home institution. Establishing feasibility of the intervention and study procedures at other trauma centers with more diverse patient populations and different clinical practices is required before a multi-site phase III efficacy-effectiveness trial. Trial registration ClinicalTrials.gov ID: NCT03405610. Registered on January 28, 2018âretrospectively registered
Grant Report on the Transcranial near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE) Study
We report on the rationale and design of an ongoing National Institute of Mental Health (NIMH) sponsored R61-R33 project in major depressive disorder (MDD). Current treatments for MDD have significant limitations in efficacy and side effect burden. There is a critical need for device-based treatments in MDD that are efficacious, well-tolerated, and easy to use. This project focuses on the adjunctive use of the transcranial photobiomodulation (tPBM) with near-infrared (NIR) light for the treatment of MDD. tPBM with NIR light penetrates robustly into the cerebral cortex, stimulating the mitochondrial respiratory chain, and also significantly increases cerebral blood flow (CBF). In the R61 phase, we will conduct target engagement studies to demonstrate dose-dependent effects of tPBM on the prefrontal cortex (PFC) CBF, using the increase in fMRI blood-oxygenation-level-dependent (BOLD) signal levels as our Go/No-go target engagement biomarker. In the R33 phase, we will conduct a randomized clinical trial of tPBM vs. sham in MDD to establish the target engagement and evaluate the association between changes in the biomarker (BOLD signal) and changes in clinical symptoms, while also collecting important information on antidepressant effects, safety, and tolerability. The study will be done in parallel at New York University/the Nathan Kline Institute (NYU/NKI) and at Massachusetts General Hospital (MGH). The importance of this study is threefold: 1. it targets MDD, a leading cause of disability worldwide, which lacks adequate treatments; 2. it evaluates tPBM, which has a well-established safety profile and has the potential to be safe in at-home administration; and 3. it uses fMRI BOLD changes as a target engagement biomarker. If effects are confirmed, the present study will both support short-term clinical development of an easy to scale device for the treatment of MDD, while also validating a biomarker for the development of future, novel modulation strategies