Test-retest reliability of the FitMáx©-questionnaire in a clinical and healthy population.

PURPOSE: The FitMáx© was developed as a questionnaire-based instrument to estimate Cardiorespiratory Fitness (CRF) expressed as oxygen uptake at peak exercise (VO2peak). Test-retest reliability is a clinometric measurement property, which defines stability over time if multiple measurements are performed (i.e. reliability). The present study aimed to assess the test-retest reliability of the FitMáx©-questionnaire in different patient groups. PATIENTS AND METHODS: A total of 127 cardiac, pulmonary and oncology patients and healthy subjects aged 19-84 years who completed the questionnaire twice within an average of 18 days were included for analysis. Participants were in a stable clinical situation (no acute disease or participating in a training program). To determine the test-retest reliability, the Intraclass Correlation Coefficient (ICC) and Standard Error of the Measurement (SEM) was calculated between the first (T0) and second (T1) administration of the questionnaires. RESULTS: An excellent agreement was found between the FitMáx©-questionnaire scores at T0 and T1, with an ICC of 0.97 (SEM 1.91) in the total study population and an ICC ranging from 0.93 to 0.98 (SEM 1.52-2.27) in the individual patient groups. CONCLUSION: The FitMáx©-questionnaire proves to be reliable and stable over time to estimate CRF of patients and healthy subjects. Trial registration NTR (Netherlands Trial Register), NL8846. Registered 25 August 2020, https://trialsearch.who.int/Trial2.aspx?TrialID=NL8846.

The impact of angles of insonation on left and right ventricular global longitudinal strain estimation in fetal speckle tracking echocardiography.

OBJECTIVES: Two-dimensional speckle tracking echocardiography has been considered an angle-independent modality. However, current literature is limited and inconclusive on the actual impact of angle of insonation on strain values. Therefore, the primary objective of this study was to assess the impact of angles of insonation on the estimation of fetal left ventricular and right ventricular global longitudinal strain. Secondarily, the impact of different definitions for angles of insonation was investigated in a sensitivity analysis. METHODS: This is a retrospective analysis of a prospective longitudinal cohort study with 124 healthy subjects. The analyses were based on the four-chamber view ultrasound clips taken between 18+0 and 21+6 weeks of gestation. Angles of insonation were categorized into three groups: up/down, oblique and perpendicular. The mean fetal left and right ventricular and global longitudinal strain values corresponding to these three groups were compared by an ANOVA test corrected for heteroscedasticity. RESULTS: Fetal left and right ventricular global longitudinal strain values were not statistically different between the three angles of insonation (p-value >0.062 and >0.149, respectively). When applying another definition for angles of insonation in the sensitivity analysis, the mean left ventricular global longitudinal strain value was significantly decreased for the oblique compared to the up/down angle of insonation (p-value 0.041). CONCLUSIONS: There is no evidence of a difference in fetal left and right ventricular global longitudinal strain between the different angles of insonation in fetal two-dimensional speckle tracking echocardiography.

The Use of Galactomannan Antigen Assays for the Diagnosis of Invasive Pulmonary Aspergillosis in the Hematological Patient: A Systematic Review and Meta-Analysis.

The optimal cut-off value of the optical density index of the galactomannan antigen assays (GM) for diagnosing invasive pulmonary aspergillosis in hematological patients is a disputed topic. This article conducts a systematic review with a meta-analysis to establish which optical density index (ODI) cut-off value should be implemented into clinical practice. Pubmed, Embase and Cochrane databases were searched (N = 27). The pooled data, using a generalized linear mixed model with binomial distribution, resulted in an overall serum sensitivity of 0.76 and a specificity of 0.92. For serum ODI 0.5 there was a pooled sensitivity of 0.92 and a specificity of 0.84. The pooled data of all broncho-alveolar lavage (BAL) studies resulted in an overall sensitivity of 0.80 and a specificity of 0.95. For BAL ODI 0.5, there was a pooled sensitivity of 0.75 and a specificity of 0.88. For the BAL ODI 1.0 pooling, the studies resulted in a sensitivity of 0.75 and a specificity of 0.96. Serum ODI of 0.5 and BAL ODI of 1.0 are the most suitable cut-offs for clinical practice. However, our study affirms that the evidence for the use of GM in clinical practice for the hematological malignancy patient is currently insufficient and more research is needed to determine the diagnostic value of GM.

Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial.

Progression of atrial fibrillation (AF) and outcomes of ablation therapy are strongly affected by modifiable risk factors. Although previous studies show beneficial effects of modifying single risk factors, there is lack of evidence from randomized controlled trials on the effects of integrated AF lifestyle programmes. The POP trial is designed to evaluate the clinical outcomes of a dedicated nurse-led AF lifestyle outpatient clinic in patients with symptomatic AF. This study is a prospective, 1:1 randomized, single centre, investigator-initiated clinical trial in 150 patients with paroxysmal or persistent AF referred for a first pulmonary vein isolation (PVI). Prior to the ablation, patients in the intervention group receive a personalized risk factor treatment programme in a specialized, protocolized, nurse-led outpatient clinic. Patient education and durable lifestyle management is promoted with an e-health platform. Patients in the control group receive standard care by cardiologists before ablation. The primary endpoint is the number of hospitalizations for re-ablation and cardioversion, with a follow-up of 12 months after ablation. Secondary endpoints include mortality, number of acute ischemic events, stroke or hospitalizations for heart failure, quality of life, number of ablations cancelled because of symptom reduction, and ablation success rate at 12 months. Determinants of patient and staff experience are explored and a cost-effectiveness analysis is included. The POP trial will help ascertain the efficacy and cost-effectiveness of an integrated technology-supported lifestyle therapy in patients with symptomatic AF. The trial is funded by the Netherlands Organisation for Health Research and Development [10070012010001]. Home sleep apnoea testing devices were provided by Itamar Medical, Ltd.ClinicalTrials.gov Identifier NCT05148338. AF atrial fibrillation, OSA obstructive sleep apnoea, PFA pulsed field ablation, PVI pulmonary vein isolation.

Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial.

Importance: Colorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient's condition in the weeks prior to surgery may attenuate these unfavorable sequelae. Objective: To determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery. Design, Setting, and Participants: The PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic. Interventions: The 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed. Main Outcomes and Measures: Comprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively. Results: In the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, -1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care. Conclusions and Relevance: This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care. Trial Registration: trialregister.nl Identifier: NTR5947.

Diagnosing Sport-Related Flow Limitations in the Iliac Arteries Using Near-Infrared Spectroscopy.

Background: A flow limitation in the iliac arteries (FLIA) in endurance athletes is notoriously difficult to diagnose with the currently available diagnostic tools. At present, a commonly used diagnostic measure is a decrease in ankle brachial index with flex hips (ABIFlexed) following a maximal effort exercise test. Near-infrared spectroscopy (NIRS) is a non-invasive technique that measures skeletal muscle oxygenation as reflected by the balance of O2 delivery from microvascular blood flow and O2 uptake by metabolic activity. Therefore, NIRS potentially serves as a novel technique for diagnosing FLIA. The purpose of this study is to compare the diagnostic accuracy of NIRS-derived absolute, amplitude, and kinetic variables in legs during and after a maximal exercise test with ABIFlexed. Methods: ABIFlexed and NIRS were studied in 33 healthy subjects and 201 patients with FLIA diagnosed with echo-Doppler. Results: After maximal exercise, NIRS kinetic variables, such as the half value time and mean response time, resulted in a range of 0.921 to 0.939 AUC for the diagnosis of FLIA when combined with ABIFlexed. Conversely, ABIFlexed measurements alone conferred significantly worse test characteristics (AUC 0.717, p < 0.001). Conclusions: NIRS may serve as a diagnostic adjunct in patients with possible FLIA.

Estimating VO2peak in 18-90 Year-Old Adults: Development and Validation of the FitMáx©-Questionnaire.

Purpose: Cardiorespiratory fitness (CRF) plays an essential role in health outcomes and quality of life. However, it is often not assessed nor estimated. Objective CRF assessment is costly, labour intensive and not widely available. Patient-reported outcome measures estimate CRF more cost-efficiently, but current questionnaires lack accuracy. The aim of this study is to develop a new self-reported questionnaire to estimate CRF. Materials and Methods: The FitMáx©-questionnaire, consisting of only three questions assessing walking, stair climbing, and cycling capacity, was compared with the commonly used Duke Activity Status Index (DASI) and Veterans Specific Activity Questionnaire (VSAQ). These questionnaires were compared to peak oxygen uptake (VO2peak) as measured with cardiopulmonary exercise testing. This study included 759 cardiac, pulmonary and oncologic patients and healthy persons aged 18‒90. Results: FitMáx© strongly correlated (r = 0.94 (0.92‒0.95) SEE = 4.14 mL∙kg-1∙min-1) with measured VO2peak. Bias between predicted and measured VO2peak was -0.24 (-9.23‒8.75; 95% limits of agreement) mL·kg-1·min-1. The FitMáx© scored superiorly on correlation and SEE compared with the DASI and VSAQ, r = 0.75 (0.68‒0.80) SEE = 4.62 mL∙kg-1∙min-1 and r = 0.87 (0.83‒0.90) SEE = 6.75 mL∙kg-1∙min-1, respectively. Conclusion: FitMáx© is a valid and accessible questionnaire to estimate CRF expressed as VO2peak in clinical practice and shows substantial improvement compared to currently used questionnaires.

Sleep-Wake Survival Dynamics in People with Insomnia.

INTRODUCTION: Assessing objective measures of sleep fragmentation could yield important features reflecting impaired sleep quality in people with insomnia. Survival analysis allows the specific examination of the stability of NREM sleep, REM sleep and wake. The objective of this study was to assess the differences between survival dynamics of NREM sleep, REM sleep and wake between people with insomnia and healthy controls. METHODS: We analyzed retrospective polysomnography recordings from 86 people with insomnia and 94 healthy controls. For each participant, survival dynamics of REM sleep, NREM sleep and wake were represented using Weibull distributions. We used lasso penalized parameter selection in combination with linear regression to analyze the difference between participant groups with respect to the Weibull scale and shape parameters, while correcting for age, sex, total sleep time and relevant interaction effects. RESULTS: Significant effects of group were found for the NREM scale parameter, and for the wake scale and shape parameters. Results indicated that people with insomnia had less stable NREM sleep and more stable wake after sleep onset compared to healthy controls. Additionally, the altered distribution of wake segment lengths indicated an increased difficulty to fall asleep after longer awakenings in the insomnia group. However, these differences were mainly observed in younger participants. Significant effects of group for the survival parameters of REM sleep were not found. CONCLUSION: As illustrated by our results, survival analysis can be very useful for disentangling different types of sleep fragmentation in people with insomnia. For instance, the current findings suggest that people with insomnia have an increased fragmentation of NREM sleep, but not necessarily of REM sleep. Additional research into the underlying mechanisms of NREM sleep fragmentation could possibly lead to a better understanding of impaired sleep quality in people with insomnia, and consequently to improved treatment.

How did governmental interventions affect the spread of COVID-19 in European countries?

BACKGROUND: To reduce the transmission of the severe acute respiratory syndrome coronavirus 2 in its first wave, European governments have implemented successive measures to encourage social distancing. However, it remained unclear how effectively measures reduced the spread of the virus. We examined how the effective-contact rate (ECR), the mean number of daily contacts for an infectious individual to transmit the virus, among European citizens evolved during this wave over the period with implemented measures, disregarding a priori information on governmental measures. METHODS: We developed a data-oriented approach that is based on an extended Susceptible-Exposed-Infectious-Removed (SEIR) model. Using the available data on the confirmed numbers of infections and hospitalizations, we first estimated the daily total number of infectious-, exposed- and susceptible individuals and subsequently estimated the ECR with an iterative Poisson regression model. We then compared change points in the daily ECRs to the moments of the governmental measures. RESULTS: The change points in the daily ECRs were found to align with the implementation of governmental interventions. At the end of the considered time-window, we found similar ECRs for Italy (0.29), Spain (0.24), and Germany (0.27), while the ECR in the Netherlands (0.34), Belgium (0.35) and the UK (0.37) were somewhat higher. The highest ECR was found for Sweden (0.45). CONCLUSIONS: There seemed to be an immediate effect of banning events and closing schools, typically among the first measures taken by the governments. The effect of additionally closing bars and restaurants seemed limited. For most countries a somewhat delayed effect of the full lockdown was observed, and the ECR after a full lockdown was not necessarily lower than an ECR after (only) a gathering ban.

Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.

RATIONALE: The mechanisms underlying impaired sleep quality in insomnia are not fully known, but an important role for sleep fragmentation has been proposed. OBJECTIVES: The aim of this study is to explore potential mechanisms of sleep fragmentation influencing alterations of perceived sleep quality. METHODS: We analyzed polysomnography (PSG) recordings from a double-blind crossover study with zopiclone 7.5 mg and placebo, in elderly participants with insomnia complaints and age-matched healthy controls. We compared survival dynamics of sleep and wake across group and treatment. Subsequently, we used a previously proposed model to estimate the amount of sleep onset latency (SOL) misperception from PSG-defined sleep fragmentation. Self-reported and model-estimated amount of SOL misperception were compared across group and treatment, as well as model prediction errors. RESULTS: In the zopiclone night, the average segment length of NREM sleep was increased (group F = 1.16, p = 0.32; treatment F = 8.89, p < 0.01; group x treatment F = 0.44, p = 0.65), while the segment length of wake was decreased (group F = 1.48, p = 0.23; treatment F = 11.49, p < 0.01; group x treatment F = 0.36, p = 0.70). The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55). The prediction error was not altered (group F = 1.62, p = 0.20; treatment F = 0.20, p = 0.65; group x treatment F = 1.01, p = 0.37). CONCLUSIONS: Impaired subjective sleep quality is associated with decreased NREM stability, together with increased stability of wake. Furthermore, we conclude that zopiclone-induced changes in SOL misperception can be largely attributed to predictable changes of sleep architecture.

Modeling sleep onset misperception in insomnia.

OBJECTIVES: To extend and validate a previously suggested model of the influence of uninterrupted sleep bouts on sleep onset misperception in a large independent data set. METHODS: Polysomnograms and sleep diaries of 139 insomnia patients and 92 controls were included. We modeled subjective sleep onset as the start of the first uninterrupted sleep fragment longer than Ls minutes, where parameter Ls reflects the minimum length of a sleep fragment required to be perceived as sleep. We compared the so-defined sleep onset latency (SOL) for various values of Ls. Model parameters were compared between groups, and across insomnia subgroups with respect to sleep onset misperception, medication use, age, and sex. Next, we extended the model to incorporate the length of wake fragments. Model performance was assessed by calculating root mean square errors (RMSEs) of the difference between estimated and perceived SOL. RESULTS: Participants with insomnia needed a median of 34 minutes of undisturbed sleep to perceive sleep onset, while healthy controls needed 22 minutes (Mann-Whitney U = 4426, p < 0.001). Similar statistically significant differences were found between sleep onset misperceivers and non-misperceivers (median 40 vs. 20 minutes, Mann-Whitney U = 984.5, p < 0.001). Model outcomes were similar across other subgroups. Extended models including wake bout lengths resulted in only marginal improvements of model outcome. CONCLUSIONS: Patients with insomnia, particularly sleep misperceivers, need larger continuous sleep bouts to perceive sleep onset. The modeling approach yields a parameter for which we coin the term Sleep Fragment Perception Index, providing a useful measure to further characterize sleep state misperception.