UNASSIGNED: Fluctuations of chronic pain levels are determined by a complex interplay of cognitive, emotional and perceptual variables. We introduce a pain tracking platform composed of wearable neurotechnology and a smartphone application to measure and predict chronic pain levels and its interplay with other dimensions of experience.
UNASSIGNED: Our method measures, dynamically and at home, pain strength, phenomenal and neural time series collected with an online tool and low-density EEG. Here we used data from a single participant who performed an attention task at home for a period of 20 days to investigate the role of attention to different bodily systems in chronic pain.
UNASSIGNED: We show a relationship between emotions and pain strength while allocating attention to the heartbeat, the breathing, the affected or the unaffected limb. We found that pain was maximal when attending to the affected limb and decreased when the participant focused on his breathing or his heartbeat. These results provide interesting insights regarding the role of attention to interoceptive signals in chronic pain. We found power changes in the delta, theta, alpha and beta (but not in the gamma) band between the four attention conditions. However, there was no reliable association of these changes to pain intensity ratings. Theta power was higher when attention was directed to the unaffected limb compared to the others. Further, the pain ratings, when attending to unaffected limb, were associated with alpha and theta power band changes.
UNASSIGNED: Overall, we demonstrate that our neurophysiology and experience tracking platform can capture how body attention allocation alters the dynamics of subjective measures and its neural correlates. This research approach is proof of concept for the development of personalized clinical assessment tools and a testbed for behavioural, subjective and biomarkers characterization.

Clinical trials with continuous primary endpoints typically measure outcomes at baseline, at a fixed timepoint (denoted Tmin), and at intermediate timepoints. The analysis is commonly performed using the mixed model repeated measures method. It is sometimes expected that the effect size will be larger with follow-up longer than Tmin. But extending the follow-up for all patients delays trial completion. We propose an alternative trial design and analysis method that potentially increases statistical power without extending the trial duration or increasing the sample size. We propose following the last enrolled patient until Tmin, with earlier enrollees having variable follow-up durations up to a maximum of Tmax. The sample size at Tmax will be smaller than at Tmin, and due to staggered enrollment, data missing at Tmax will be missing completely at random. For analysis, we propose an alpha-adjusted procedure based on the smaller of the p values at Tmin and Tmax, termed minP $$ minP $$ . This approach can provide the highest power when the powers at Tmin and Tmax are similar. If the power at Tmin and Tmax differ significantly, the power of minP $$ minP $$ is modestly reduced compared with the larger of the two powers. Rare disease trials, due to the limited size of the patient population, may benefit the most with this design.

This study investigates individual performance adaptations on 2 years of training between European Aerobics Championships. An elite, 22-year-old aerobic gymnast performed postural coordination test, Y-Balance test, squat and countermovement jumps, 60 s test of repeated jumps, an isokinetic leg muscle strength test, and the Wingate test. Postural stability and flexibility improved in terms of increased distance achieved in the Y-Balance test in the anterior (by 6.3%), posteromedial (by 2%), and posterolateral (by 4.8%) directions. Lower limb muscular endurance also increased, which can be corroborated by a reduced fatigue index in the 60 s test of repeated jumps (from 42% to 27% after the 1st and to 22% after the 2nd year of training). In addition, mean power increased during dominant (by 23.2% at 60°/s and by 18.5% at 180°/s) and non-dominant leg extension (by 4.9% at 180°/s and by 15.5% at 300°/s), plus dominant leg flexion (by 2.0% at 60°/s and by 6.9% at 300°/s). Similarly, peak torque/body weight ratio increased during dominant (by 24.9% at 60°/s, by 11.5% at 180°/s, and by 2.1% at 300°/s) and non-dominant leg extension (by 0.5% at 60°/s and by 6.4% at 300°/s), plus dominant leg flexion (by 1.7% at 60°/s and by 5.4% at 300°/s). However, 2 years of training failed to show any significant improvements in the explosive power of lower limbs and anaerobic performance. These findings indicate that general aerobic gymnastics training without any specific inputs leads to performance adaptation, namely, in abilities closely related to competition routine (dynamic balance and strength endurance of lower limbs).

OBJECTIVE: To explore the applicable conditions of the Cox-TEL (Cox PH-Taylor expansion adjustment for long-term survival data) method for analysis of survival data that contain cured patients.
METHODS: The simulated survival data method based on Weibull distribution was used to simulate and generate the survival data with different cure rates, censored rates, and cure rate differences. The Cox-TEL method was used for analysis of the generated simulation data, and its performance was evaluated by calculating its type Ⅰ error and power.
RESULTS: Almost all the type Ⅰ error of the hazard ratios (HRs) obtained by the Cox-TEL method under different conditions were slightly greater than 0.05, and this method showed a good test power for estimating the HRs for data with a large sample size and a large difference in proportions (DPs). For the data of cured patients, the type Ⅰ error of the DPs obtained by the Cox-TEL method was well around 0.05, and its test power was robust in most of the scenarios.
CONCLUSIONS: The Cox-TEL method is effective for analyzing data of uncured patients and obtaining reliable HRs for most of the survival data with a sample size, a low censored rates, and a large difference in cure rates. The method is capable of accurately estimating the DPs regardless of the sample size, censored rates, or the cure rates.

Dose-scale pharmacodynamic bioequivalence is recommended for evaluating the consistency of generic and innovator formulations of certain locally acting drugs, such as orlistat. This study aimed to investigate the standard methodology for sample size determination and the impact of study design on dose-scale pharmacodynamic bioequivalence using orlistat as the model drug. A population pharmacodynamic model of orlistat was developed using NONMEM 7.5.1 and utilized for subsequent simulations. Three different study designs were evaluated across various predefined relative bioavailability ratios of test/reference (T/R) formulations. These designs included Study Design 1 (2×1 crossover with T1 60 mg, R1 60 mg, and R2 120 mg), Study Design 2 (2×1 crossover with T2 120 mg, R1 60 mg, and R2 120 mg), and Study Design 3 (2×2 crossover with T1 60 mg, T2 120 mg, R1 60 mg, and R2 120 mg). Sample sizes were determined using a stochastic simulation and estimation approach. Under the same T/R ratio and power, Study Design 3 required the minimum sample size for bioequivalence, followed by Study Design 1, while Study Design 2 performed the worst. For Study Designs 1 and 3, a larger sample size was needed on the T/R ratio < 1.0 side for the same power compared to that on the T/R ratio > 1.0 side. The opposite asymmetry was observed for Study Design 2. We demonstrated that Study Design 3 is most effective for reducing the sample size for orlistat bioequivalence studies, and the impact of T/R ratio on sample size shows asymmetry.

UNASSIGNED: To investigate the acute effects of ingesting a beverage containing guarana (Paullinia cupana) seed powder on performance during field tests related to physical capacities that are determinants of soccer performance, such as lower limb power, sprint, agility, and the capacity to carry out intermittent exercise.
UNASSIGNED: The study was conducted using a randomized, crossover, and counterbalanced design, with a beverage containing guarana or placebo administered in a double-blind manner. Twenty-seven under-17 soccer players of a professional soccer club performed a battery of tests 60 min after the ingestion of guarana (3 g of the fruit seed powder) or placebo. Trials were performed with a 7-day washout period. The battery of tests included a countermovement jump test, sprints of 10 and 20 m, an Illinois agility test, and a Yo-Yo Intermittent Recovery Test level 1 (YYIR1).
UNASSIGNED: Guarana ingestion did not improve countermovement jump, sprints, or agility (p > 0.05). However, guarana ingestion increased the distance covered in the YYIR1, compared with placebo ingestion (p = 0.01).
UNASSIGNED: Acute ingestion of guarana improves the capacity to perform intermittent exercise in soccer players but seems to be ineffective to improve lower limb power, sprint, and agility.

UNASSIGNED: This study examined the effects of 8-week complex training (CT) with blood flow restriction (BFR) on power output and bar velocity.
UNASSIGNED: Twenty-six healthy male university athletes (age: 19.40 ± 0.88 years) completed three sessions of CT with BFR (CT_BFRT, n = 13) or CT-only (i.e., control) (n = 13) per week (i.e., 24 sessions in total). Before and immediately after intervention, participants completed power measurement as assessed by one-repetition maximum (1RM) squat, squat jump (SJ), countermovement jump (CMJ), and mean power (MP), peak power (PP), mean bar velocity (Bar-MV), and peak bar velocity (Bar-PV) during the half-squat jump.
UNASSIGNED: Two-way ANOVA models showed significant main effect of time (p < 0.001) but not group (p > 0.89) or interaction (p > 0.37) between group and time on 1RM of the squat, SJ, or CMJ; however, significant interactions were observed in MP (p = 0.03, Cohen\'s d = 1.39), PP (p = 0.03, Cohen\'s d = 1.14), Bar-MV (p = 0.049, Cohen\'s d = 1.26), and Bar-PV (p = 0.01, Cohen\'s d = 1.56). The post hoc analyses revealed that MP, PP, Bar-MV, and Bar-PV after CT with BFRT were significantly greater compared to all the other three conditions (i.e., pre-CT_BFRT, pre- and post-CT-only).
UNASSIGNED: CT with BFR may induce significantly greater improvements in power output and bar velocity during half-squat jump and induce comparable improvements in 1RM of the squat, SJ, and CMJ of males as compared to CT only, suggesting this novel CT with BFR would be a promising strategy to enhance power performance in healthy male university athletes.

We give examples of three features in the design of randomized controlled clinical trials which can increase power and thus decrease sample size and costs. We consider an example multilevel trial with several levels of clustering. For a fixed number of independent sampling units, we show that power can vary widely with the choice of the level of randomization. We demonstrate that power and interpretability can improve by testing a multivariate outcome rather than an unweighted composite outcome. Finally, we show that using a pooled analytic approach, which analyzes data for all subgroups in a single model, improves power for testing the intervention effect compared to a stratified analysis, which analyzes data for each subgroup in a separate model. The power results are computed for a proposed prevention research study. The trial plans to randomize adults to either telehealth (intervention) or in-person treatment (control) to reduce cardiovascular risk factors. The trial outcomes will be measures of the Essential Eight, a set of scores for cardiovascular health developed by the American Heart Association which can be combined into a single composite score. The proposed trial is a multilevel study, with outcomes measured on participants, participants treated by the same provider, providers nested within clinics, and clinics nested within hospitals. Investigators suspect that the intervention effect will be greater in rural participants, who live farther from clinics than urban participants. The results use published, exact analytic methods for power calculations with continuous outcomes. We provide example code for power analyses using validated software.

Background: Despite the acknowledged importance of resistance training (RT) in enhancing physical performance in futsal players., the comparative effectiveness of RT and complex training (CT) on both physical and technical performance in futsal players remains underexplored. This study aimed to compare the effects of RT vs. CT on physical and technical performance in amateur futsal players. Method: Players from two amateur futsal teams were assigned to RT (one team of 16 players; 18 years) and CT (one team of 16 players; 18 years) to perform an 8-week intervention with two weekly sessions. The RT performed the squat and deadlift (6 sets of 6-10 repetitions at 75%-85% one-repetition maximum (1RM), while the CT performed the squat + squat jump and deadlift + high pull (3 sets of 4-6 + 10-12 repetitions at 75%-85% 1RM). Pre- and post-intervention assessments included the Futsal Special Performance Test (FSPT), repeated sprint ability (RSA), sprint decrement (Sdec), sprint times at 10-m (T10), 10-20-m (T10-20), and 20-m (T20), 1RM back squat (1RM BS), isometric mid-thigh pull (IMTP), and countermovement jump (CMJ). Results: At baseline, no significant differences between groups were observed for any variable analyzed (p > 0.05). After 8 weeks, there were significant differences between CT vs. RT on FSPT (-10.8% vs. -3.4%; p < 0.05), T10 (-5.2% vs. -0.1%; p < 0.05), IMTP (7.8% vs. 5.1%; p < 0.05), and CMJ (10.2% vs. 4.5%; p < 0.05). On the other hand, no significant differences between CT vs. RT were observed for RSA (-2.0% vs. -1.2%; p > 0.05), Sdec (-7.6% vs. -3.5%; p > 0.05), T10-20 (-0.9% vs. -0.9%; p > 0.05), T20 (-1.8% vs. -1.7%; p > 0.05), and 1RM BS (5.7% vs. 4.5%; p > 0.05) after the training program. Both groups significantly improved FSPT, T20, 1RM BS, and IMTP, while only CT significantly improved RSA, Sdec, T10, and CMJ. Conclusion: The results suggest that CT may be valuable for improving specific performance parameters in amateur futsal players, with some advantages over RT in enhancing strength and power. These findings support tailored training protocols for futsal players to optimize performance.

Patient and public involvement and engagement (PPIE) is an increasingly important component of research conduct to enhance processes and potential for impact, yet is rarely critically interrogated. This paper draws on Foucauldian analysis to highlight the disciplinary powers and tensions arising in PPIE. The paper draws on a nested evaluation interview study with three PPIE members and eight academics, who had been involved in an implementation science study focused on palliative care. PPIE members were involved in the whole study and are co-authors of this article. Through shared values and commitments to the study, a team culture of equality was developed. Yet while power was dispersed and taken-up by all team members, in so doing a self-governance approach within the team was developed. The pace and focus of discussions was at times more subjugating than co-production. Identities and positions were porous; the simplistic division of \'academic\' and \'PPIE\' did not stand up to scrutiny, with an increasing blurring of boundaries as people\'s experiences and insights changed over time. Continual, subtle, negotiations of roles, inputs and identities were manifest throughout the project. PPIE in research involves subtle, complex and ongoing disciplinary practices enacted by all members of the team.