Motivation A single monoclonal broadly neutralizing antibody (bnAb) regimen was recently evaluated in two randomized trials for prevention efficacy against HIV-1 infection. Subsequent trials will evaluate combination bnAb regimens (e.g., cocktails, multi-specific antibodies), which demonstrate higher potency and breadth in vitro compared to single bnAbs. Given the large number of potential regimens, methods for down-selecting these regimens into efficacy trials are of great interest. Results We developed Super LeArner Prediction of NAb Panels (SLAPNAP), a software tool for training and evaluating machine learning models that predict in vitro neutralization sensitivity of HIV Envelope (Env) pseudoviruses to a given single or combination bnAb regimen, based on Env amino acid sequence features. SLAPNAP also provides measures of variable importance of sequence features. By predicting bnAb coverage of circulating sequences, SLAPNAP can improve ranking of bnAb regimens by their potential prevention efficacy. In addition, SLAPNAP can improve sieve analysis by defining sequence features that impact bnAb prevention efficacy. Availability SLAPNAP is a freely available docker image that can be downloaded from DockerHub (https://hub.docker.com/r/slapnap/slapnap). Source code and documentation are available at GitHub (respectively, https://github.com/benkeser/slapnap and https://benkeser.github.io/slapnap/). Supplementary information Supplementary data are available at Bioinformatics online.
Background Electronic self-monitoring technology has the potential to provide unique insights into important behaviors for inducing weight loss. Objective The aim of this study is to investigate the effects of electronic self-monitoring behavior (using the commercial Lose It! app) and weight loss interventions (with differing amounts of counselor feedback and support) on 4- and 12-month weight loss. Methods In this secondary analysis of the Fit Blue study, we compared the results of two interventions of a randomized controlled trial. Counselor-initiated participants received consistent support from the interventionists, and self-paced participants received assistance upon request. The participants (N=191), who were active duty military personnel, were encouraged to self-monitor their diet and exercise with the Lose It! app or website. We examined the associations between intervention assignment and self-monitoring behaviors. We conducted a mediation analysis of the intervention assignment for weight loss through multiple mediators—app use (calculated from the first principal component [PC] of electronically collected variables), number of weigh-ins, and 4-month weight change. We used linear regression to predict weight loss at 4 and 12 months, and the accuracy was measured using cross-validation. Results On average, the counselor-initiated–treatment participants used the app more frequently than the self-paced–treatment participants. The first PC represented app use frequencies, the second represented calories recorded, and the third represented reported exercise frequency and exercise caloric expenditure. We found that 4-month weight loss was partially mediated through app use (ie, the first PC; 60.3%) and the number of weigh-ins (55.8%). However, the 12-month weight loss was almost fully mediated by 4-month weight loss (94.8%). Linear regression using app data from the first 8 weeks, the number of self–weigh-ins at 8 weeks, and baseline data explained approximately 30% of the variance in 4-month weight loss. App use frequency (first PC; P=.001), self-monitored caloric intake (second PC; P=.001), and the frequency of self-weighing at 8 weeks (P=.008) were important predictors of 4-month weight loss. Predictions for 12-month weight with the same variables produced an R2 value of 5%; only the number of self–weigh-ins was a significant predictor of 12-month weight loss. The R2 value using 4-month weight loss as a predictor was 31%. Self-reported exercise did not contribute to either model (4 months: P=.77; 12 months: P=.15). Conclusions We found that app use and daily reported caloric intake had a substantial impact on weight loss prediction at 4 months. Our analysis did not find evidence of an association between participant self-monitoring exercise information and weight loss. As 12-month weight loss was completely mediated by 4-month weight loss, intervention targets should focus on promoting early and frequent dietary intake self-monitoring and self-weighing to promote early weight loss, which leads to long-term success. Trial Registration ClinicalTrials.gov NCT02063178; https://clinicaltrials.gov/ct2/show/NCT02063178
6501 Background: IBM Watson for Clinical Trial Matching (CTM) is a cognitive computing solution that uses natural language processing (NLP) to help increase the efficiency and accuracy of the clinical trial matching process. This solution helps providers locate suitable protocols for their patients by reading the trial criteria and matching it to the structured and unstructured patient characteristics when integrated with the Electronic Medical Record (EMR). It is also designed to determine which sites have the most viable patient population and identify inclusion and exclusion criteria that limit enrollment. Methods: This project was a collaboration among Highlands Oncology Group (HOG), Novartis and IBM Watson Health to explore the use of CTM in a community oncology practice. HOG is in Northeast Arkansas and has 15 physicians and 310 staff members working across 3 sites. During the 16-week pilot period, data from 2,620 visits by lung and breast cancer patients were processed by the CTM system. Using NLP capabilities, CTM read the clinical trial protocols provided by Novartis, and evaluated the patient data against the protocols’ inclusion and exclusion criteria. Watson excluded ineligible patients, determined those that needed further screening, and assisted in that process. Feedback on the user experience was also obtained. Results: In an initial pre-screening test, the HOG clinical trial coordinator (CTC) took 1 hour and 50 minutes to process 90 patients against 3 breast cancer protocols. Conversely, when the CTM screening solution was used, it took 24 minutes. This represents a significant reduction in time of 86 minutes or 78%. Watson excluded 94% of the patients automatically, providing criteria level evidence regarding the reason for exclusion, thus reducing the screening workload dramatically. Conclusions: IBM Watson CTM can help expedite the screening of patient charts for clinical trial eligibility and therefore may also help determine the feasibility of protocols to optimize site selection and enable higher and more efficient trial accruals.
Background: Back mice, or episacroiliac lipoma, represent a potentially treatable cause of low back pain that may be under-recognized in clinical practice. Despite being well characterized based on clinical history and physical examination findings, implementation of appropriate treatment may be delayed or missed based on a lack of familiarity with the diagnosis. Objectives: In this case report and literature review, we describe a 47-year-old woman with history of persistent low back pain who presented with a pain exacerbation consistent with a back mouse. The history, epidemiology, clinical characteristics, differential diagnosis, potential mechanisms for pain, and treatment options for back mice were then reviewed. Study Design: Case report and literature review. Setting: Academic university-based pain management center. Results: Studies included one randomized clinical trial, 4 cross-sectional studies, 8 case reports or series, and 16 other publications prior to 1967. Limitations: A single case report. Conclusions: Firm, rubbery, mobile nodules that are located in characteristic regions of the sacroiliac, posterior superior iliac, and the lumbar paraspinal regions may represent fatty tissue that has herniated through fascial layers. When painful, these back mice may be confused with other causes of low back pain. In particular, the presence of point tenderness may mimic myofascial pain, and reports of radicular pain may imitate herniated nucleus pulposus. However, back mice may be distinguished from other entities based on findings from the history and physical examination such as absence of neurological deficit. Treatment consisting of injection of local anesthetic into the nodule with or without corticosteroid followed by repeated, direct needling has been reported to relieve pain in many case reports. The one clinical trial comparing injection of local anesthetic to normal saline, which did not include repeated needling, found only mild and transient benefit in the treatment group. Key words: Low back pain, back mice, back mouse, episacroiliac lipoma, lumbar subcutaneous nodules, multifidus triangle syndrome, subcutaneous fatty nodes, case report, review
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