Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: The ZIKAlliance consortium

Background: The European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic. Methods: Recruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1-3, 4-6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmissio

Creative destruction in science

Drawing on the concept of a gale of creative destruction in a capitalistic economy, we argue that initiatives to assess the robustness of findings in the organizational literature should aim to simultaneously test competing ideas operating in the same theoretical space. In other words, replication efforts should seek not just to support or question the original findings, but also to replace them with revised, stronger theories with greater explanatory power. Achieving this will typically require adding new measures, conditions, and subject populations to research designs, in order to carry out conceptual tests of multiple theories in addition to directly replicating the original findings. To illustrate the value of the creative destruction approach for theory pruning in organizational scholarship, we describe recent replication initiatives re-examining culture and work morality, working parents\u2019 reasoning about day care options, and gender discrimination in hiring decisions. Significance statement It is becoming increasingly clear that many, if not most, published research findings across scientific fields are not readily replicable when the same method is repeated. Although extremely valuable, failed replications risk leaving a theoretical void\u2014 reducing confidence the original theoretical prediction is true, but not replacing it with positive evidence in favor of an alternative theory. We introduce the creative destruction approach to replication, which combines theory pruning methods from the field of management with emerging best practices from the open science movement, with the aim of making replications as generative as possible. In effect, we advocate for a Replication 2.0 movement in which the goal shifts from checking on the reliability of past findings to actively engaging in competitive theory testing and theory building. Scientific transparency statement The materials, code, and data for this article are posted publicly on the Open Science Framework, with links provided in the article

Reproducibility in the absence of selective reporting : An illustration from large-scale brain asymmetry research

Altres ajuts: Max Planck Society (Germany).The problem of poor reproducibility of scientific findings has received much attention over recent years, in a variety of fields including psychology and neuroscience. The problem has been partly attributed to publication bias and unwanted practices such as p-hacking. Low statistical power in individual studies is also understood to be an important factor. In a recent multisite collaborative study, we mapped brain anatomical left-right asymmetries for regional measures of surface area and cortical thickness, in 99 MRI datasets from around the world, for a total of over 17,000 participants. In the present study, we revisited these hemispheric effects from the perspective of reproducibility. Within each dataset, we considered that an effect had been reproduced when it matched the meta-analytic effect from the 98 other datasets, in terms of effect direction and significance threshold. In this sense, the results within each dataset were viewed as coming from separate studies in an "ideal publishing environment," that is, free from selective reporting and p hacking. We found an average reproducibility rate of 63.2% (SD = 22.9%, min = 22.2%, max = 97.0%). As expected, reproducibility was higher for larger effects and in larger datasets. Reproducibility was not obviously related to the age of participants, scanner field strength, FreeSurfer software version, cortical regional measurement reliability, or regional size. These findings constitute an empirical illustration of reproducibility in the absence of publication bias or p hacking, when assessing realistic biological effects in heterogeneous neuroscience data, and given typically-used sample sizes

Biofeedback treatment in patients with refractory epilepsy: Changes in depression and control orientation

AbstractDepression is a common and serious interictal problem in patients with epilepsy. The genesis of depressive disorders is multifactorial. One aetiological aspect focuses on psychosocial factors. It was hypothesized that uncontrollable, unpredictable chronic aversive events (i.e. epileptic seizures) result in cognitive deficits ofexternal control orientation. If this is true, biofeedback training could represent a possible treatment strategy to lower depression, because biofeedback is known to mediate success experiences and control. Measures of depression and locus of control were administered to 20 patients with refractory partial epilepsy before and after biofeedback treatment. The biofeedback consisted of slow cortical potentials or breathing parameters in 10 patients each. A clear relationship occurred between depression and locus of control in the subjects. After biofeedback training control orientation moved towards a more internal locus of control. Also, depression scores were significantly reduced six months after training. Results show that in patients with refractory epilepsy depression is highly correlated with locus of control, in a way that external control orientation relates to high depression scores. Biofeedback is able to improve internal control orientation through personal success mediation

Biofeedback as complementary treatment in patients with epilepsy – an underestimated therapeutic option? Review, results, discussion

Background. Biofeedback methods represent side effect free complementary options in the treatment of epilepsy. In this paper we review the current status of these methods in terms of clinical study results and their evaluation by systematic review papers. Possible mechanisms of action in biofeedback methods are discussed

The screen for cognitive impairment in psychiatry (SCIP) as a routinely applied screening tool: pathology of acute psychiatric inpatients and cluster analysis

Background: Cognitive dysfunction has been reported in acute psychiatric patients for a long time. The detection of cognitive deficits is crucial both for clinical treatment and for predicting the psychosocial functional level in the further course of the disease. The SCIP is a well-evaluated screening instrument for the examination of cognitive performance in psychiatric patients. We recently integrated the SCIP into our routine admission and discharge assessments on two inpatient wards, and we examined the cognitive profiles of patients with psychotic and affective disorders over the course of their admission. Methods: Shortly after admission, and prior to discharge, patients were routinely referred for examination with the SCIP. A total of 529 assessments were completed on admission, and 227 returned for SCIP at the time of discharge. After standardization of the test results against a normative sample, we examined the normalized test values in terms of percentages of pathological cognitive performance based on the total SCIP score, and each of the SCIP subscale scores. We conducted cluster analysis to identify cognitive subgroups within the clinical sample. Results: More than 70% of the SCIP results on admission were pathological. At discharge, improvements were observed, especially on tests with attention and speed components. Cluster analysis identified two groups. The cluster with chronic patients showed poorer results at admission, but greater improvement and reached the level of the others at discharge. Conclusions: The SCIP appears to have value in routine diagnostic assessments, and in the quantification of improvements in cognitive performance during an inpatient stay. The greatest benefit was observed in chronically ill patients with many previous stays. Trial registration: DRKS00019825 (retrospectively registered on 03.12.2019)