Data collection quality assurance in cross-national surveys: the example of the ESS

"The significance of cross-national surveys for the social sciences has increased over the past decades and with it the number of cross-national datasets that researchers have access to. Cross-national surveys are typically large enterprises that demand dedicated efforts to coordinate the process of data collection in the participating countries. While cross-national surveys have addressed many important methodological problems, such as translation and the cultural applicability of concepts, the management of the data collection process has yet had little place in cross-national survey methodology. This paper describes the quality standards for data collection and their monitoring in the European Social Survey (ESS). In the ESS data are collected via face-to-face interviewing. In each country a different survey organisation carries out the data collection. Assuring the quality across the large number of survey organisations is a complex but indispensable task to achieve valid and comparable data." (author's abstract)"International vergleichende Umfragen haben in den vergangenen Jahrzehnten zunehmende Bedeutung in den Sozialwissenschaften erlangt. Diese Umfragen sind für gewöhnlich große Unterfangen, die gezielte Anstrengungen zur Koordinierung der Datenerhebung in den teilnehmenden Ländern erfordern. Probleme des Managements der Datenerhebung bei international vergleichenden Umfragen haben bislang jedoch nur wenig Aufmerksamkeit gefunden, im Unterschied etwa zu anderen methodischen Herausforderungen wie Fragen der Übersetzung oder der interkulturellen Übertragbarkeit von theoretischen Konzepten. Der vorliegende Beitrag beschreibt die Qualitätsstandards für die Datenerhebung und deren Überwachung im European Social Survey (ESS). Im ESS werden Daten in persönlich-mündlichen Interviews erhoben; in jedem Teilnehmerland ist ein anderes Umfrageinstitut mit der Feldarbeit betraut. Um valide und vergleichbare Daten zu erzielen, sind Maßnahmen zur Sicherung der Qualität der Datenerhebung über die große Zahl von Umfrageinstituten hinweg unverzichtbar." (Autorenreferat

Impact of Dose Adaptations Following Voriconazole Therapeutic Drug Monitoring in Pediatric Patients

This manuscript was derived from chapter 9 of the PhD thesis by Vincent Lempers done at Radboudumc, which can be found at: https://repository.ubn.ru.nl/bitstream/handle/2066/157075/157075.pdf?sequence=1 AW is supported by the Wellcome Trust Strategic Award (grant 097377), and the MRC Centre for Medical Mycology (grant MR/N006364/1) at the University of Aberdeen. Funding: this study was funded by the Department of Pharmacy RadboudumcPeer reviewedPostprin

The BAF complex inhibitor pyrimethamine reverses HIV-1 latency in people with HIV-1 on antiretroviral therapy

Reactivation of the latent HIV-1 reservoir is a first step toward triggering reservoir decay. Here, we investigated the impact of the BAF complex inhibitor pyrimethamine on the reservoir of people living with HIV-1 (PLWH). Twenty-eight PLWH on suppressive antiretroviral therapy were randomized (1:1:1:1 ratio) to receive pyrimethamine, valproic acid, both, or no intervention for 14 days. The primary end point was change in cell-associated unspliced (CA US) HIV-1 RNA at days 0 and 14. We observed a rapid, modest, and significant increase in (CA US) HIV-1 RNA in response to pyrimethamine exposure, which persisted throughout treatment and follow-up. Valproic acid treatment alone did not increase (CA US) HIV-1 RNA or augment the effect of pyrimethamine. Pyrimethamine treatment did not result in a reduction in the size of the inducible reservoir. These data demonstrate that the licensed drug pyrimethamine can be repurposed as a BAF complex inhibitor to reverse HIV-1 latency in vivo in PLWH, substantiating its potential advancement in clinical studies.</p

Tumor-specific uptake of fluorescent bevacizumab-IRDye800CW microdosing in patients with primary breast cancer:a phase I feasibility study

PURPOSE: to provide proof of principle of safety, breast tumor-specific uptake and positive tumor margin assessment of the systemically administered near-infrared fluorescent (NIRF) tracer bevacizumab-IRDye800CW targeting vascular endothelial growth factor (VEGF)-A in breast cancer patients. EXPERIMENTAL DESIGN: Twenty patients with primary invasive breast cancer eligible for primary surgery received 4.5 mg bevacizumab-IRDye800CW as intravenous bolus injection. Safety aspects were assessed as well as tracer uptake and tumor delineation during surgery and ex vivo in surgical specimens using an optical imaging system. Ex vivo multiplexed histopathology analyses were performed for evaluation of biodistribution of tracer uptake and co-registration of tumor tissue and healthy tissue. RESULTS: None of the patients experienced adverse events. Tracer levels in primary tumor tissue were higher compared to those in the tumor margin (P < 0.05) and healthy tissue (P < 0.0001). VEGF-A tumor levels also correlated with tracer levels (r = 0.63, P < 0.0002). All but one tumor showed specific tracer uptake. Two out of 20 surgically excised lumps contained microscopic positive margins detected ex vivo by fluorescent macro- and microscopy and confirmed at the cellular level. CONCLUSIONS: Our study shows that systemic administration of the bevacizumab-IRDye800CW tracer is safe for breast cancer guidance and confirms tumor and tumor-margin uptake as evaluated by a systematic validation methodology. The findings are a step towards a phase II dose-finding study aimed at in vivo margin assessment and point to a novel drug assessment tool that provides a detailed picture of drug distribution in tumor tissue

Three’s Company: An Additional Non-transiting Super-Earth in the Bright HD 3167 System, and Masses for All Three Planets

HD 3167 is a bright (V = 8.9), nearby K0 star observed by the NASA K2 mission (EPIC 220383386), hosting two small, short-period transiting planets. Here we present the results of a multi-site, multi-instrument radial velocity campaign to characterize the HD 3167 system. The masses of the transiting planets are 5.02±0.38 MEarth for HD 3167 b, a hot super-Earth with a likely rocky composition (ρb = 5.60+2.15-1.43g cm-3), and 9.80+1.30-1.24 MEarth for HD 3167 c, a warm sub-Neptune with a likely substantial volatile complement (ρc = 1.97+0.94-0.59 g cm-3). We explore the possibility of atmospheric composition analysis and determine that planet c is amenable to transmission spectroscopy measurements, and planet b is a potential thermal emission target. We detect a third, non-transiting planet, HD 3167 d, with a period of 8.509+/-0.045 d (between planets b and c) and a minimum mass of 6.90±0.71 MEarth. We are able to constrain the mutual inclination of planet d with planets b and c: we rule out mutual inclinations below 1.3 degrees as we do not observe transits of planet d. From 1.3-40 degrees, there are viewing geometries invoking special nodal configurations which result in planet d not transiting some fraction of the time. From 40-60 degrees, Kozai-Lidov oscillations increase the system's instability, but it can remain stable for up to 100Myr. Above 60 degrees, the system is unstable. HD 3167 promises to be a fruitful system for further study and a preview of the many exciting systems expected from the upcoming NASATESS mission.Publisher PDFPeer reviewe

The 2021 WHO catalogue of Mycobacterium tuberculosis complex mutations associated with drug resistance: a genotypic analysis.

Background: Molecular diagnostics are considered the most promising route to achievement of rapid, universal drug susceptibility testing for Mycobacterium tuberculosis complex (MTBC). We aimed to generate a WHO-endorsed catalogue of mutations to serve as a global standard for interpreting molecular information for drug resistance prediction. Methods: In this systematic analysis, we used a candidate gene approach to identify mutations associated with resistance or consistent with susceptibility for 13 WHO-endorsed antituberculosis drugs. We collected existing worldwide MTBC whole-genome sequencing data and phenotypic data from academic groups and consortia, reference laboratories, public health organisations, and published literature. We categorised phenotypes as follows: methods and critical concentrations currently endorsed by WHO (category 1); critical concentrations previously endorsed by WHO for those methods (category 2); methods or critical concentrations not currently endorsed by WHO (category 3). For each mutation, we used a contingency table of binary phenotypes and presence or absence of the mutation to compute positive predictive value, and we used Fisher's exact tests to generate odds ratios and Benjamini-Hochberg corrected p values. Mutations were graded as associated with resistance if present in at least five isolates, if the odds ratio was more than 1 with a statistically significant corrected p value, and if the lower bound of the 95% CI on the positive predictive value for phenotypic resistance was greater than 25%. A series of expert rules were applied for final confidence grading of each mutation. Findings: We analysed 41 137 MTBC isolates with phenotypic and whole-genome sequencing data from 45 countries. 38 215 MTBC isolates passed quality control steps and were included in the final analysis. 15 667 associations were computed for 13 211 unique mutations linked to one or more drugs. 1149 (7·3%) of 15 667 mutations were classified as associated with phenotypic resistance and 107 (0·7%) were deemed consistent with susceptibility. For rifampicin, isoniazid, ethambutol, fluoroquinolones, and streptomycin, the mutations' pooled sensitivity was more than 80%. Specificity was over 95% for all drugs except ethionamide (91·4%), moxifloxacin (91·6%) and ethambutol (93·3%). Only two resistance mutations were identified for bedaquiline, delamanid, clofazimine, and linezolid as prevalence of phenotypic resistance was low for these drugs. Interpretation: We present the first WHO-endorsed catalogue of molecular targets for MTBC drug susceptibility testing, which is intended to provide a global standard for resistance interpretation. The existence of this catalogue should encourage the implementation of molecular diagnostics by national tuberculosis programmes. Funding: Unitaid, Wellcome Trust, UK Medical Research Council, and Bill and Melinda Gates Foundation

Pacemaker exteriorization

status: Published onlin

Data collection quality assurance in cross-national surveys at the example of the ESS

"The significance of cross-national surveys for the social sciences has increased over the past decades and with it the number of cross-national datasets that researchers have access to. Cross-national surveys are typically large enterprises that demand dedicated efforts to coordinate the process of data collection in the participating countries. While cross-national surveys have addressed many important methodological problems, such as translation and the cultural applicability of concepts, the management of the data collection process has yet had little place in cross-national survey methodology. This paper describes the quality standards for data collection and their monitoring in the European Social Survey (ESS). In the ESS data are collected via face-to-face interviewing. In each country a different survey organisation carries out the data collection. Assuring the quality across the large number of survey organisations is a complex but indispensable task to achieve valid and comparable data." (author's abstract)"International vergleichende Umfragen haben in den vergangenen Jahrzehnten zunehmende Bedeutung in den Sozialwissenschaften erlangt. Diese Umfragen sind für gewöhnlich große Unterfangen, die gezielte Anstrengungen zur Koordinierung der Datenerhebung in den teilnehmenden Ländern erfordern. Probleme des Managements der Datenerhebung bei international vergleichenden Umfragen haben bislang jedoch nur wenig Aufmerksamkeit gefunden, im Unterschied etwa zu anderen methodischen Herausforderungen wie Fragen der Übersetzung oder der interkulturellen Übertragbarkeit von theoretischen Konzepten. Der vorliegende Beitrag beschreibt die Qualitätsstandards für die Datenerhebung und deren Überwachung im European Social Survey (ESS). Im ESS werden Daten in persönlich-mündlichen Interviews erhoben; in jedem Teilnehmerland ist ein anderes Umfrageinstitut mit der Feldarbeit betraut. Um valide und vergleichbare Daten zu erzielen, sind Maßnahmen zur Sicherung der Qualität der Datenerhebung über die große Zahl von Umfrageinstituten hinweg unverzichtbar." (Autorenreferat