Lab meets real life : a laboratory assessment of spontaneous thought and its ecological validity

People's minds frequently wander towards self-generated thoughts, which are unrelated to external stimuli or demands. These phenomena, referred to as "spontaneous thought" (ST) and "mind wandering" (MW), have previously been linked with both costs and benefits. Current assessments of ST and MW have predominantly been conducted in the laboratory, whereas studies on the ecological validity of such lab-related constructs and their interrelations are rare. The current study examined the stability of ST dimensions assessed in the lab and their predictive value with respect to MW, repetitive negative thought (uncontrollable rumination, RUM), and affect in daily life. Forty-three university students were assessed with the Amsterdam Resting State Questionnaire (2nd version) to assess ten ST dimensions during the resting state in two laboratory sessions, which were separated by five days of electronic ambulatory assessment (AA). During AA, individuals indicated the intensity of MW and RUM, as well as of positive and negative affect in daily life ten times a day. ST dimensions measured in the lab were moderately stable across one week. Five out of ten ST lab dimensions were predicted by mental health-related symptoms or by dispositional cognitive traits. Hierarchical linear models revealed that a number of ST lab dimensions predicted cognitive and affective states in daily life. Mediation analyses showed that RUM, but not MW per se, accounted for the relationship between specific ST lab dimensions and mood in daily life. By using a simple resting state task, we could demonstrate that a number of lab dimensions of spontaneous thought are moderately stable, are predicted by mental health symptoms and cognitive traits, and show plausible associations with categories of self-generated thought and mood in daily life

Regulatory delays in a multinational clinical stroke trial

INTRODUCTION: The initiation and conduct of randomised clinical trials are complicated by multiple barriers, including delays in obtaining regulatory approvals. Quantitative data on the extent of the delays due to national or local review in randomised clinical trials is scarce. MATERIALS AND METHODS: We assessed the times needed to obtain regulatory approval and to initiate a trial site for an academic, EU-funded, phase III, randomised clinical trial of pharmacological prevention of complications in patients with acute stroke in over 80 sites in nine European countries. The primary outcome was the time from the first submission to a regulatory authority to initiation of a trial site. Secondary outcomes included time needed to complete each individual preparatory requirement and the number of patients recruited by each site in the first 6 and 12 months. RESULTS: The median time from the first submission to a regulatory authority to initiation of a trial site was 784 days (IQR: 586–1102). The single most time-consuming step was the conclusion of a clinical trial agreement between the national coordinator and the trial site, which took a median of 194 days (IQR: 93–293). A longer time to site initiation was associated with a lower patient recruitment rate in the first six months after initiation (B = –0.002; p = 0.02). DISCUSSION: CONCLUSION: In this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials

Quantitative High-Resolution Genomic Analysis of Single Cancer Cells

During cancer progression, specific genomic aberrations arise that can determine the scope of the disease and can be used as predictive or prognostic markers. The detection of specific gene amplifications or deletions in single blood-borne or disseminated tumour cells that may give rise to the development of metastases is of great clinical interest but technically challenging. In this study, we present a method for quantitative high-resolution genomic analysis of single cells. Cells were isolated under permanent microscopic control followed by high-fidelity whole genome amplification and subsequent analyses by fine tiling array-CGH and qPCR. The assay was applied to single breast cancer cells to analyze the chromosomal region centred by the therapeutical relevant EGFR gene. This method allows precise quantitative analysis of copy number variations in single cell diagnostics

Prevention of infections and fever to improve outcome in older patients with acute stroke (PRECIOUS): a randomised, open, phase III, multifactorial, clinical trial with blinded outcome assessment

BackgroundInfections and fever after stroke are associated with poor functional outcome or death. We assessed whether prophylactic treatment with anti-emetic, antibiotic, or antipyretic medication would improve functional outcome in older patients with acute stroke. MethodsWe conducted an international, 2∗2∗2-factorial, randomised, controlled, open-label trial with blinded outcome assessment in patients aged 66 years or older with acute ischaemic stroke or intracerebral haemorrhage and a score on the National Institutes of Health Stroke Scale ≥ 6. Patients were randomly allocated (1:1) to metoclopramide (oral, rectal, or intravenous; 10 mg thrice daily) vs. no metoclopramide, ceftriaxone (intravenous; 2000 mg once daily) vs. no ceftriaxone, and paracetamol (oral, rectal, or intravenous; 1000 mg four times daily) vs. no paracetamol, started within 24 h after symptom onset and continued for four days. All participants received standard of care. The target sample size was 3800 patients. The primary outcome was the score on the modified Rankin Scale (mRS) at 90 days analysed with ordinal logistic regression and reported as an adjusted common odds ratio (an acOR 1 harm). This trial is registered (ISRCTN82217627). FindingsFrom April 2016 through June 2022, 1493 patients from 67 European sites were randomised to metoclopramide (n = 704) or no metoclopramide (n = 709), ceftriaxone (n = 594) or no ceftriaxone (n = 482), and paracetamol (n = 706) or no paracetamol (n = 739), of whom 1471 were included in the intention-to-treat analysis. Prophylactic use of study medication did not significantly alter the primary outcome at 90 days: metoclopramide vs. no metoclopramide (adjusted common odds ratio [acOR], 1.01; 95% CI 0.81–1.25), ceftriaxone vs. no ceftriaxone (acOR 0.99; 95% CI 0.77–1.27), paracetamol vs. no paracetamol (acOR 1.19; 95% CI 0.96–1.47). The study drugs were safe and not associated with an increased incidence of serious adverse events. InterpretationWe observed no sign of benefit of prophylactic use of metoclopramide, ceftriaxone, or paracetamol during four days in older patients with a moderately severe to severe acute stroke. FundingThis project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No: 634809

Happy thoughts: Mind wandering affects mood in daily life

Mind wandering is often thought to have adverse consequences such as to deteriorate mood. However, more recent findings suggest that the effect of mind wandering on mood may depend on the specific thought contents that occur during mind-wandering episodes and may be influenced by trait-like interindividual differences. The current study examined prospective effects of mind wandering (MW) on mood in daily life as well as possible moderating effects of dispositional mindfulness and rumination. Forty-three university students aged 19 to 32 (61% women) filled out questionnaires on trait mindfulness and rumination. Subsequently, they underwent 5 days of electronic ambulatory assessment of MW and positive and negative affect in daily life ten times a day. Prospective models revealed positive effects of MW on mood, and negative affect was lowest when thoughts during MW were most pleasant. Although dispositional rumination and mindfulness significantly affected mood in daily life, no moderating effects of these traits were identified on the association between MW and mood. These results suggest that mind wandering is not a negative phenomenon per se but instead has adaptive consequences that can lead to mood improvements. Our findings highlight the importance of accounting for the thought content of mind-wandering episodes when investigating the functional outcomes of a wandering mind. Given that mind wandering frequently takes place in everyday life, interventions that encourage individuals to shift the content of their mind-wandering experiences towards pleasant topics may have an important impact particularly for clinical populations

Anxiety and rumination moderate menstrual cycle effects on mood in daily life

Evidence for menstrual cycle-related mood fluctuations in the general population of women has been mixed. While most previous research has relied on retrospective self-report and did not consider possible moderators, the present study aimed to examine cycle-related mood variations in daily life and possible moderating effects of anxiety and trait rumination. We examined 59 women aged 18-44 years with natural menstrual cycles between January and October 2012. Mood components of calmness, positive valence, energetic-arousal, and irritability were assessed using smartphones by ambulatory assessment ten times per day on eight days across the cycle. The menstrual, follicular, ovulatory, and late luteal phases were each covered by two consecutive assessment days. Moderators were assessed with questionnaires. Hierarchical linear models revealed higher calmness in the luteal and menstrual than in the follicular and ovulatory phase, while menstrual cycle did not exhibit significant main effects on other mood components. Anxiety and ruminative self-reflection moderated the association between menstrual cycle and all mood variables. Specifically, highly anxious and ruminative women showed an increase in irritability, while women with lower anxiety and lower rumination were protected against mood deterioration toward the end of the cycle. Further research could examine whether reducing anxiety and rumination helps to prevent PMS-related syndromes

Effects of ARSQ 2.0 MW dimensions on mind wandering, rumination, and positive and negative affect in daily life.

<p>Effects of ARSQ 2.0 MW dimensions on mind wandering, rumination, and positive and negative affect in daily life.</p

Hierarchical Linear Models on the Effect of Symptoms and Dispositional Traits on Mind Wandering Dimensions in the Laboratory (ARSQ 2.0, Day 1, Day7, backward regression).

<p>Hierarchical Linear Models on the Effect of Symptoms and Dispositional Traits on Mind Wandering Dimensions in the Laboratory (ARSQ 2.0, Day 1, Day7, backward regression).</p