Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study.</p> <p>Methods/Design</p> <p>STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session.</p> <p>Clinical Trials Registry</p> <p>ClinicalTrials.gov, <a href="http://www.clinicaltrials.gov/ct2/show/NCT01141608">NCT01141608</a></p> <p><url>http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1</url></p

Large expert-curated database for benchmarking document similarity detection in biomedical literature search

Document recommendation systems for locating relevant literature have mostly relied on methods developed a decade ago. This is largely due to the lack of a large offline gold-standard benchmark of relevant documents that cover a variety of research fields such that newly developed literature search techniques can be compared, improved and translated into practice. To overcome this bottleneck, we have established the RElevant LIterature SearcH consortium consisting of more than 1500 scientists from 84 countries, who have collectively annotated the relevance of over 180 000 PubMed-listed articles with regard to their respective seed (input) article/s. The majority of annotations were contributed by highly experienced, original authors of the seed articles. The collected data cover 76% of all unique PubMed Medical Subject Headings descriptors. No systematic biases were observed across different experience levels, research fields or time spent on annotations. More importantly, annotations of the same document pairs contributed by different scientists were highly concordant. We further show that the three representative baseline methods used to generate recommended articles for evaluation (Okapi Best Matching 25, Term Frequency-Inverse Document Frequency and PubMed Related Articles) had similar overall performances. Additionally, we found that these methods each tend to produce distinct collections of recommended articles, suggesting that a hybrid method may be required to completely capture all relevant articles. The established database server located at https://relishdb.ict.griffith.edu.au is freely available for the downloading of annotation data and the blind testing of new methods. We expect that this benchmark will be useful for stimulating the development of new powerful techniques for title and title/abstract-based search engines for relevant articles in biomedical research.Peer reviewe

Factors Associated With Emergency Department Length of Stay and In-hospital Mortality in Intracerebral Hemorrhage Patients

BACKGROUND: Spontaneous intracerebral hemorrhage (ICH) is a medical emergency that requires rapid identification and focused assessment early to ensure the best possible outcomes. The purpose of this study is to evaluate the associations between system and patient factors and emergency department (ED) length of stay and in-hospital mortality in patients given a diagnosis of ICH. METHODS: A sample of 3108 ICH patients was selected from a statewide administrative database for cross-sectional retrospective analysis. System characteristic (hospital stroke certification), patient characteristics (age, sex, and race), and covariate conditions (stroke severity and comorbidities) were analyzed using descriptive statistics and hierarchical logistic regression models to address the study questions. RESULTS: The mean ED length of stay is 2.9 ± 3 hours (range, 0-42 hours) before admission to an inpatient unit. Inpatient mortality is 14.9%. Stroke center certification (P \u3c .000) and stroke severity (P ≤ .000) are significant predictors of ED length of stay, whereas age (P \u3c .000), stroke severity (P \u3c .000), comorbidities (P = .047), and ED length of stay (P = .04) are significant predictors of in-hospital mortality. Most notably, an ED length of stay of 3 hours or longer has a 37% increase in the odds of in-hospital mortality. CONCLUSION: Our findings support age, stroke severity, and ED length of stay as predictors of in-hospital mortality for ICH patients. The importance of timely admission to an inpatient unit is emphasized. Optimal systems of care and expedited inpatient admission are vital to reduce morbidity and mortality for ICH stroke patients

Factors Associated With Emergency Department Length of Stay and In-hospital Mortality in Intracerebral Hemorrhage Patients

BACKGROUND: Spontaneous intracerebral hemorrhage (ICH) is a medical emergency that requires rapid identification and focused assessment early to ensure the best possible outcomes. The purpose of this study is to evaluate the associations between system and patient factors and emergency department (ED) length of stay and in-hospital mortality in patients given a diagnosis of ICH. METHODS: A sample of 3108 ICH patients was selected from a statewide administrative database for cross-sectional retrospective analysis. System characteristic (hospital stroke certification), patient characteristics (age, sex, and race), and covariate conditions (stroke severity and comorbidities) were analyzed using descriptive statistics and hierarchical logistic regression models to address the study questions. RESULTS: The mean ED length of stay is 2.9 ± 3 hours (range, 0-42 hours) before admission to an inpatient unit. Inpatient mortality is 14.9%. Stroke center certification (P \u3c .000) and stroke severity (P ≤ .000) are significant predictors of ED length of stay, whereas age (P \u3c .000), stroke severity (P \u3c .000), comorbidities (P = .047), and ED length of stay (P = .04) are significant predictors of in-hospital mortality. Most notably, an ED length of stay of 3 hours or longer has a 37% increase in the odds of in-hospital mortality. CONCLUSION: Our findings support age, stroke severity, and ED length of stay as predictors of in-hospital mortality for ICH patients. The importance of timely admission to an inpatient unit is emphasized. Optimal systems of care and expedited inpatient admission are vital to reduce morbidity and mortality for ICH stroke patients

Predictors of Time to Aneurysm Repair and Mortality in Aneurysmal Subarachnoid Hemorrhage

BACKGROUND : Prompt aneurysm repair is essential to prevent rebleeding after aneurysmal subarachnoid hemorrhage. To date, most studies on this topic have focused on 1 set of predictors (eg, hospital or patient characteristics) and on 1 outcome (either time to aneurysm repair or mortality). The purpose of this study was to test a model that includes hospital and patient characteristics as predictors of time to aneurysm repair and mortality, controlling for disease severity and comorbidity, and considering time to aneurysm repair as a potential influence in these relationships. METHODS : A sample of aneurysmal subarachnoid hemorrhage patients with a principal procedure of clipping or coiling was selected (n = 387) from a statewide administrative database for cross-sectional retrospective analysis. The primary study outcome was in-hospital mortality. Independent variables were level of stroke center, age, race, sex, and type of aneurysm repair. Hierarchical logistic regression was used to estimate the probability of in-hospital death. RESULTS : Patients who underwent a coiling procedure were more likely to be treated within the first 24 hours of admission compared with those undergoing clipping (odds ratio, 0.54; 95% CI, 0.35-0.84; P = .01). Patients treated at a certified comprehensive stroke center (CSC) had a 72% reduction in odds of death compared with those treated at primary stroke centers (odds ratio, 0.28; 95% CI, 0.10-0.77; P = .01), after controlling for disease severity and comorbid conditions. Time to aneurysm repair was not significantly associated with mortality and did not influence the relationship between hospital and patient characteristics and mortality. CONCLUSION : Our results indicate that treatment at a CSC was associated with a lower risk of in-hospital mortality. Time to aneurysm repair did not influence mortality and did not explain the mortality benefit observed in CSCs. Research is needed to explore interdisciplinary hospital factors including nursing and nurse-sensitive interventions that may explain the relationship between CSCs and mortality outcomes

Factors Associated With Recurrent Ischemic Stroke in the Medical Group of the SAMMPRIS Trial

IMPORTANCE: The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial showed that aggressive medical therapy was more effective than stenting for preventing stroke in patients with symptomatic intracranial stenosis. However, 15% of patients in the medical group still experienced a primary end point during a median follow-up of 32.7 months. OBJECTIVE: To determine baseline features that were associated with a high rate of a primary end point in the medical arm of the SAMMPRIS Trial. DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis of patients in the medical arm only of the SAMMPRIS trial. Enrollment occurred between October 2008 and April 2013 and included 227 patients randomized to medical management alone. Baseline demographic features, vascular risk factors, qualifying event, brain imaging, and angiographic features were analyzed. Bivariate and multivariable proportional hazard regression modeling was performed to relate baseline features to the time until a primary end point. The post hoc analysis was conducted from November 2014 to June 2015. INTERVENTIONS: The SAMMPRIS Trial compared stenting with aggressive medical management in patients with a stroke or transient ischemic attack attributed to 70% to 99% stenosis of a major intracranial artery. MAIN OUTCOMES AND MEASURES: The primary outcome was any of the following: stroke or death within 30 days of enrollment, ischemic stroke in the territory of the symptomatic intracranial artery beyond 30 days after enrollment, or any stroke or death within 30 days after stenting a patient in the medical group during follow-up. RESULTS: A total of 227 patients were included in the study, 82 of whom were female, and the mean (SD) age was 59.5 (11.8) years. Being female (hazard ratio [HR], 1.9; 95% CI, 0.96-3.7), having diabetes mellitus (HR, 1.8; 95% CI, 0.9-3.5), not taking a statin at enrollment (HR, 2.6; 95% CI, 1.2-5.7), stroke as the qualifying event (HR, 2.5; 95% CI, 1.03-6.0), Rankin grade of 1 or greater (HR, 2.3; 95% CI, 0.9-5.5), old infarct in the territory of the stenotic artery (HR, 2.6; 95% CI, 1.3-5.1), and greater than 80% stenosis (HR, 1.9; 95% CI, 0.9-3.7) were associated (P \u3c .10) with higher risk on bivariate analysis. Factors that were significantly associated with a primary end point on multivariable analyses were old infarct in the territory (HR, 2.6; 95% CI, 1.3-5.3; P = .006), stroke as the qualifying event (HR, 3.0; 95% CI, 1.1-7.7; P = .03), and no statin use at enrollment (HR, 2.4; 95% CI, 1.1-5.2; P = .03). CONCLUSIONS AND RELEVANCE: Old infarct in the territory of the stenosis, new stroke presentation, and absence of statin use at enrollment were independently associated with high rates of the primary end point in the medical group in the SAMMPRIS Trial. These features may be useful for selecting high-risk patients for future clinical trials evaluating alternative therapies for intracranial stenosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00576693