In this placebo-controlled trial of patients in a vegetative or minimally conscious state, amantadine accelerated functional recovery. Recovery slowed after amantadine was discontinued, and ...functional outcomes at 6 weeks were similar in the amantadine and placebo groups.
Severe traumatic brain injury is a catastrophic event that frequently has devastating familial, economic, and societal consequences. Traumatic brain injury is the most common cause of death and disability in persons between 15 and 30 years of age.
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The most severe injuries can result in prolonged disorders of consciousness. Approximately 10 to 15% of patients with severe traumatic brain injury are discharged from acute care in a vegetative state,
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a condition in which there is wakefulness without behavioral evidence of conscious awareness.
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The estimated prevalence of a minimally conscious state,
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which is distinguished from a vegetative state by the presence . . .
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a new human disease with few effective treatments
. Convalescent plasma, donated by ...persons who have recovered from COVID-19, is the acellular component of blood that contains antibodies, including those that specifically recognize SARS-CoV-2. These antibodies, when transfused into patients infected with SARS-CoV-2, are thought to exert an antiviral effect, suppressing virus replication before patients have mounted their own humoral immune responses
. Virus-specific antibodies from recovered persons are often the first available therapy for an emerging infectious disease, a stopgap treatment while new antivirals and vaccines are being developed
. This retrospective, propensity score-matched case-control study assessed the effectiveness of convalescent plasma therapy in 39 patients with severe or life-threatening COVID-19 at The Mount Sinai Hospital in New York City. Oxygen requirements on day 14 after transfusion worsened in 17.9% of plasma recipients versus 28.2% of propensity score-matched controls who were hospitalized with COVID-19 (adjusted odds ratio (OR), 0.86; 95% confidence interval (CI), 0.75-0.98; chi-square test P value = 0.025). Survival also improved in plasma recipients (adjusted hazard ratio (HR), 0.34; 95% CI, 0.13-0.89; chi-square test P = 0.027). Convalescent plasma is potentially effective against COVID-19, but adequately powered, randomized controlled trials are needed.
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FZAB, GEOZS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Abstract Hart T, Bagiella E. Design and implementation of clinical trials in rehabilitation research. The growth of evidence-based medicine means that both researchers and clinicians must grasp the ...complex issues involved in implementing clinical trials, which are especially challenging for the behavioral (experience-based) treatments that predominate in rehabilitation. In this article we discuss selected issues germane to the design, implementation, and analysis of group-level clinical trials in rehabilitation. We review strengths, weaknesses, and best applications of 1-sample, between-subjects, and within-subjects study designs, including newer models such as practical clinical trials and point-of-care trials. We also discuss the selection of appropriate control conditions against which to test rehabilitation treatments, as well as issues related to trial blinding. In a section on treatment definition, we discuss the challenges of specifying the active ingredients in the complex interventions that are widely used in rehabilitation, and present an illustration of 1 approach to defining treatments via the learning mechanisms that underlie them. Issues related to treatment implementation are also discussed, including therapist allocation and training, and assessment of treatment fidelity. Finally we consider 2 statistical topics of particular importance to many rehabilitation trials: the use of multiple or composite outcomes, and factors that must be weighed in estimating sample size for clinical trials.
Background
Patients who have had COVID-19 often report persistent symptoms after resolution of their acute illness. Recent reports suggest that vaccination may be associated with improvement in ...post-acute symptoms. We used data from a prospective cohort to assess differences in post-acute sequelae of COVID (PASC) among vaccinated vs. unvaccinated patients.
Methods
We used data from a cohort of COVID-19 patients enrolled into a prospective registry established at a tertiary care health system in New York City. Participants underwent a baseline evaluation before COVID-19 vaccines were available and were followed 6 months later. We compared unadjusted and propensity score–adjusted baseline to 6-month change for several PASC–related symptoms and measures: anosmia, respiratory (cough, dyspnea, phlegm, wheezing), depression, anxiety, post-traumatic stress disorder (PTSD; COVID-19-related and other trauma), and quality-of-life domains among participants who received vs. those who did not receive COVID-19 vaccination.
Results
The study included 453 COVID-19 patients with PASC, of which 324 (72%) were vaccinated between the baseline and 6-month visit. Unadjusted analyses did not show significant differences in the baseline to 6-month change in anosmia, respiratory symptoms, depression, anxiety, PTSD, or quality of life (
p
> 0.05 for all comparisons) among vaccinated vs. unvaccinated patients. Similar results were found in propensity-adjusted comparisons and in secondary analyses based on the number of vaccine doses received.
Conclusions
Our findings suggest that COVID vaccination is not associated with improvement in PASC. Additional studies are needed to better understand the mechanisms underlying PASC and to develop effective treatments.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
This clinical trial compared mitral-valve repair with replacement for severe ischemic mitral regurgitation. There were no significant between-group differences in left ventricular remodeling and ...clinical outcomes, but replacement was associated with more durable correction.
Functional ischemic mitral regurgitation affects 1.6 million to 2.8 million patients in the United States and is associated with a doubling in mortality among patients with mild or greater degrees of mitral regurgitation after myocardial infarction.
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Ischemic mitral regurgitation is a consequence of adverse left ventricular remodeling after myocardial injury with enlargement of the left ventricular chamber and mitral annulus, apical and lateral migration of the papillary muscles, leaflet tethering, and reduced closing forces. These processes lead to malcoaptation of the leaflets and variable degrees of mitral regurgitation that can fluctuate dynamically as a function of volume status, afterload, . . .
In this trial, patients with atrial fibrillation undergoing mitral-valve surgery were assigned to surgical ablation of AF or no ablation. At 6 and 12 months, more patients in the ablation group were ...free from AF, but more patients in that group required permanent pacemakers.
Atrial fibrillation, which is associated with reduced survival and increased risk of stroke, is present in 30 to 50% of patients presenting for mitral-valve surgery.
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The development of open surgical procedures for the ablation of atrial fibrillation has led to their widespread application during cardiac operations, but their effectiveness and safety have not been rigorously established. It is hypothesized that long-term outcomes can be improved by successful ablation in patients with preexisting persistent or long-standing persistent atrial fibrillation who are undergoing mitral-valve surgery.
The Cox maze III operation (sometimes called the “cut-and-sew” maze operation) is a complex surgical procedure . . .
Abstract Bagiella E. Clinical trials in rehabilitation: single or multiple outcomes? In clinical trials, the choice of the primary outcome affects the study design, the sample size calculations, the ...data analysis, and the interpretation of the study results. Most importantly, it may determine the future of the intervention being studied. In several clinical and rehabilitation settings, a single primary outcome measure is often not sufficient to reflect the effect of an intervention because attention is focused on multiple aspects of patients' recovery. In stroke and traumatic brain injuries trials, for example, functional recovery is as important as cognitive recovery. Thus, a trial with a functional scale alone as the primary outcome would not be informative about the effectiveness of the intervention on cognitive functions. From the methodologic point of view, the choice of multiple primary outcomes presents several challenges, including selecting a measure, among several, to be used for sample size calculations; dealing with multiple comparisons; and interpreting the results. In this article, we discuss a global test procedure that allows investigators to use several binary measures as primary outcomes in a clinical trial. This procedure offers an efficient solution under very reasonable assumptions, avoids loss of power caused by multiple comparisons, has greater statistical power than any single outcome measure, and is easily interpreted and of direct clinical interest.
The aims of the present study were: 1) to investigate the contribution of the extent of luminal stenosis and other lesion composition-related factors in predicting invasive fractional flow reserve ...(FFR); and 2) to explore the distribution of various combinations of morphological characteristics and the severity of stenosis among lesions demonstrating normal and abnormal FFR.
In patients with stable ischemic heart disease, FFR-guided revascularization, as compared with medical therapy alone, is reported to improve outcomes. Because morphological characteristics are the basis of plaque rupture and acute coronary events, a relationship between FFR and lesion characteristics may exist.
This is a subanalysis of NXT (HeartFlowNXT: HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography), a prospective, multicenter study of 254 patients (age 64 ± 10 years, 64% male) with suspected stable ischemic heart disease; coronary computed tomography angiography including plaque morphology assessment, invasive angiography, and FFR were obtained for 383 lesions. Ischemia was defined by invasive FFR ≤0.80. Computed tomography angiography–defined morphological characteristics of plaques and their vascular location were used in univariate and multivariate analyses to examine their predictive value for invasive FFR. The distribution of various combinations of plaque morphological characteristics and the severity of stenosis among lesions demonstrating normal and abnormal FFR were examined.
The percentage of luminal stenosis, low-attenuation plaque (LAP) or necrotic core volume, left anterior descending coronary artery territory, and the presence of multiple lesions per vessel were the predictors of FFR. When grouped on the basis of degree of luminal stenosis, FFR-negative lesions had consistently smaller LAP volumes compared with FFR-positive lesions. The distribution of plaque characteristics in lesions with normal and abnormal FFR demonstrated that whereas FFR-negative lesions excluded likelihood of stenotic plaques with moderate to high LAP volumes, only one-third of FFR-positive lesions demonstrated obstructive plaques with moderate to high LAP volumes.
In addition to the severity of luminal stenosis, necrotic core volume is an independent predictor of FFR. The distribution of plaque characteristics among lesions with varying luminal stenosis and normal and abnormal FFR may explain the outcomes associated with FFR-guided therapy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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