Search

The article discusses the use of the win ratio as a method for evaluating evidence from clinical trials. The win ratio allows for the inclusion of patient-reported outcomes and surrogate measures in addition to traditional clinical outcomes like death and hospitalization. However, the win ratio has limitations, such as the difficulty in prioritizing component events and the potential for the inclusion of unimportant events. The article provides examples of how the win ratio can lead to overestimation of treatment effects or be driven by biased measures. Overall, the utility of the win ratio depends on the prespecified definition and ranking of clinically relevant components. [Extracted from the article]

Countermovement jump (CMJ) performance has been routinely used to monitor neuromuscular status. However, the protocol used to establish the criterion score is not well documented. The purpose of this study was to examine how the protocol used would influence of the sensitivity of CMJ variables in rugby union players. Fifteen male (age: 19.7 ± 0.5 years) rugby union players performed 8 CMJs on 2 occasions, separated by 7 days. The between-session coefficient of variation (CV) was calculated using 2 techniques for treating multiple trials, the average, and the trial with the best jump height (JH), and then compared with the smallest worthwhile change (SWC). The signal-to-noise ratio was measured as the group mean change in a variable divided by the CV. Using the average value across multiple trials is superior to the best trial method, based on lower CVs for all variables. Only the average performance across 6 or more trials was classified as ideal (CV < 0.5 x SWC) for peak velocity (PV). In addition, the signal-to-noise ratio for peak concentric power (PCP), PV, and JH were classified as good, irrespective of the treatment method. Although increasing the number of trials can reduce the random error, it may be pragmatic to simply take the average from 2 to 3 trials, facilitating a CV < SWC for PV, PCP, and JH. Due to its simplicity, JH may be considered the principal variable to monitor neuromuscular fatigue. [ABSTRACT FROM AUTHOR]

As previously reported, PARAGON-HF narrowly missed statistical significance for its primary end point (rate ratio, 0.87 [95% CI, 0.75-1.01]; I P i =0.059).[2] It is noteworthy that 28% (566 cases) of potential HF hospitalizations identified by investigators were negatively adjudicated by the CEC. This mean probability for each event was then used in a multiple imputation procedure, creating 1000 imputed data sets with CEC-unconfirmed events included or not based on their probability (random draw from a respective Bernoulli distribution), such that an event with an average probability of 40% would be expected to be included as a HF hospitalization in 400 of 1000 data sets. Keywords: clinical trial; heart failure; hospitalization; probability; sacubitril-valsartan; valsartan EN clinical trial heart failure hospitalization probability sacubitril-valsartan valsartan 2316 2318 3 06/10/21 20210608 NES 210608 Heart failure with preserved ejection fraction is a highly morbid condition with few proven treatment options. [Extracted from the article]

To explore whether HR analysis was appropriate, we reconstructed patient-level survival data from the Kaplan-Meier curves presented in the CHARM-Overall article.[3] Here, the reconstructed Kaplan-Meier curves are presented in Figure, A. Because the Kaplan-Meier curves separate initially but remain parallel after 0.5 years, the PH assumption was not met, as was confirmed via the Schoenfeld goodness-of-fit test ( I P i =0.0005). Using the reconstructed Kaplan-Meier curves in the Figure (D), the 12-month RMSTs were 11.41 and 11.36 months for biodegradable and durable stents, respectively. [Extracted from the article]

Background--Guidelines for the management of patients with suspected coronary artery disease (CAD) rely on the age, sex, and angina typicality-based pretest probabilities of angiographically significant CAD derived from invasive coronary angiography (guideline probabilities). Reliability of guideline probabilities has not been investigated in patients referred to noninvasive CAD testing. Methods and Results--We identified 14048 consecutive patients with suspected CAD who underwent coronary computed tomographic angiography. Angina typicality was recorded with the use of accepted criteria. Pretest likelihood of CAD with ≥50% diameter stenosis (CAD50) and ≥70% diameter stenosis (CAD70) were calculated from guideline probabilities. Computed tomographic angiography images were evaluated by ≥1 expert reader to determine the presence of CAD50 and CAD70. Typical angina was associated with the highest prevalence of CAD50 (40% in men, 19% in women) and CAD70 (27% men, 11% women) compared with other symptom categories (P<0.001 for all). Observed CAD50 and CAD70 prevalences were substantially lower than those predicted by guideline probabilities in the overall population (18% versus 51% for CAD50, 10% versus 42% for CAD70: P<0.001), driven by pronounced differences in patients with atypical angina (15% versus 47% tbr CAD50, 7% versus 37% for CAD71)) and typical angina (29% versus 86% for CAD50, 19% versus 71% for CAD70). Marked overestimation of disease prevalence by guideline probabilities was found at all participating centers and across all sex and age subgroups. Conclusion--In this multinational study of patients referred for coronary computed tomographic angiography, determination of pretest likelihood of angiographically significant CAD by the invasive angiography-based guideline probabilities greatly overestimates the actual prevalence of disease. [ABSTRACT FROM AUTHOR]

Abstract: A wide variety of risk factors for the occurrence and prognostic factors for persistence of non-specific musculoskeletal pain (MSP) are mentioned in the literature. A systematic review of all these factors is not available. Thus a systematic review was conducted to evaluate MSP risk factors and prognostic factors, classified according to the dimensions of the International Classification of Functioning, Disability and Health. Candidate systematic reviews were identified in electronic medical journal databases, including the articles published between January 2000 and January 2008 that employed longitudinal cohort designs. The GRADE Working Group’s criteria for assessing the overall level of evidence were used to evaluate the reviews. Nine systematic reviews were included, addressing a total of 67 factors. High evidence supported increased mobility of the lumbar spine and poor job satisfaction as risk factors for low back pain. There was also high evidence for intense pain during the onset of shoulder and neck pain and being middle aged as risk factors for shoulder pain. High evidence was also found for several factors that were not prognostic factors. For whiplash-associated disorders these factors were older age, being female, having angular deformity of the neck, and having an acute psychological response. Similarly, for persistence of low back pain, high evidence was found for having fear-avoidance beliefs and meagre social support at work. For low back pain, high evidence was found for meagre social support and poor job content at work as not being risk factors. [Copyright &y& Elsevier]

Keywords: confidence intervals; decision making; physics; probability; randomized controlled trial When the effect of a new drug is evaluated in a clinical trial, the investigators report an estimate of the effect size, which is presented in probabilistic terms (ie, confidence intervals). Confidence intervals, decision making, physics, probability, randomized controlled trial. [Extracted from the article]

Laser evoked potentials (LEPs) are brain responses to activation of skin nociceptors by laser heat stimuli. LEPs consist of three components: N1, N2, and P2. Previous reports have suggested that in contrast to earlier activities (N1), LEPs responses after 230–250 ms (N2–P2) are modulated by attention to painful laser stimuli. However, the experimental paradigms used were not designed to specify the attentional processes involved in these LEP modulations. We investigated the effects of selective spatial attention and oddball tasks on LEPs. CO2 laser stimuli of two different intensities were delivered on the dorsum of both hands of ten subjects. One intensity was frequently presented, and the other rarely. Subjects were asked to pay attention to stimuli delivered on one hand and to count rare stimuli, while ignoring stimuli on the other hand. Frequent and rare attended stimuli evoked enhanced N160 (N1) and N230 (N2) components in comparison to LEPs from unattended stimuli. Both components showed scalp distribution contralateral to the stimulus location. The vertex P400 (P2) was unaffected by spatial attention and stimulus location, but its amplitude increased after rare stimuli, whether attended or unattended. An additional parietal P600 component was induced by the attended rare stimuli. It is suggested that several attentional processes can modify nociceptive processing in the brain at different stages. LEP activities in the time-range of N1 and N2 (120–270 ms) showed evidence of processes modulated by the direction of spatial attention. Conversely, processes underlying P2 (400 ms) were not affected by spatial attention, but by the probability of the stimulus. This probability effect was not due to P3b-related processes that were observed at a later latency (600 ms). Indeed, P600 could be seen as a P3b evoked by conscious detection of rare targets. [Copyright &y& Elsevier]