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Sabine Fuchs Britta Olberg Matthias Perleth Reinhard Busse Dimitra Panteli 《Health policy (Amsterdam, Netherlands)》2019,123(2):173-181
Objective
Medical devices (MDs) encompass a broad and heterogeneous range of technologies. While practices vary considerably across countries, MDs often find application in patient care with little or no evaluation of their effectiveness and safety following market approval. A recently proposed taxonomy of MDs considered devices from the viewpoint of Health Technology Assessment (HTA). The aim of the work presented here was to test its plausibility and applicability by considering real-world HTA practices.Methods
HTA reports on MDs from European institutions were collected in a systematic manner and the evaluated devices and/or related procedures were matched to a position on the taxonomy. Following this, representatives from 16 European HTA institutions were asked about the usefulness of the taxonomy in semi-structured interviews.Results
1237 HTA reports (2004–2015) from 33 European institutions were included in the sample. The majority of reports was on technologies from the taxonomic positions initially estimated as having high relevance. Most of the experts interviewed stated that they found the taxonomy useful, particularly regarding its potential to aid in selecting technologies for assessment and to highlight potential methodological particularities per taxonomic position.Conclusions
Overall, the distribution of identified reports on the matrix confirmed that the initial estimation of the relevance and necessity of HTA provided in the taxonomic model is plausible. In addition, interviews with representatives of European HTA institutions showed that the taxonomy could be useful. 相似文献4.
Gabriel Ziegler Michael Moutoussis Tobias U. Hauser Pasco Fearon Edward T. Bullmore Ian M. Goodyer Peter Fonagy Peter B. Jones Ulman Lindenberger Raymond J. Dolan 《Human brain mapping》2020,41(12):3392-3402
Socio‐economic disadvantage increases exposure to life stressors. Animal research suggests early life stressors impact later neurodevelopment, including myelin developmental growth. To determine how early life disadvantage may affect myelin growth in adolescence and young adulthood, we analysed data from an accelerated longitudinal neuroimaging study measuring magnetisation transfer (MT), a myelin‐sensitive marker, in 288 participants (149 female) between 14 and 25 years of age at baseline. We found that early life economic disadvantage before age 12, measured by a neighbourhood poverty index, was associated with slower myelin growth. This association was observed for magnetization transfer in cortical, subcortical and core white matter regions, and also in key subcortical nuclei. Participant IQ at baseline, alcohol use, body mass index, parental occupation and self‐reported parenting quality did not account for these effects, but parental education did so partially. Specifically, positive parenting moderated the effect of socio‐economic disadvantage in a protective manner. Thus, early socioeconomic disadvantage appears to alter myelin growth across adolescence. This finding has potential translational implications, including clarifying whether reducing socio‐economic disadvantage during childhood, and increasing parental education and positive parenting, promote normal trajectories of brain development in economically disadvantaged contexts. 相似文献
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Christian Herder Alexandra Schneider Siqi Zhang Kathrin Wolf Haifa Maalmi Cornelia Huth Regina Pickford Michael Laxy Gidon J. Bnhof Wolfgang Koenig Wolfgang Rathmann Michael Roden Annette Peters Barbara Thorand Dan Ziegler 《Environmental health perspectives》2020,128(12)
Background: Air pollution contributes to type 2 diabetes and cardiovascular diseases, but its relevance for other complications of diabetes, in particular distal sensorimotor polyneuropathy (DSPN), is unclear. Recent studies have indicated that DSPN is also increasingly prevalent in obesity.Objectives: We aimed to assess associations of air pollutants with prevalent and incident DSPN in a population-based study of older individuals with high rates of type 2 diabetes and obesity.Methods: Cross-sectional analyses on prevalent DSPN were based on 1,075 individuals 62–81 years of age from the German Cooperative Health Research in the Region of Augsburg (KORA) F4 survey (2006–2008). Analyses on incident DSPN included 424 individuals without DSPN at baseline (KORA F4), of whom 188 had developed DSPN by the KORA FF4 survey (2013–2014). Associations of annual average air pollutant concentrations at participants’ residences with prevalent and incident DSPN were estimated using Poisson regression models with a robust error variance adjusting for multiple confounders.Results: Higher particle number concentrations (PNCs) were associated with higher prevalence [risk ratio (RR) per interquartile range (IQR) (95% CI: 1.01, 1.20)] and incidence [1.11 (95% CI: 0.99, 1.24)] of DSPN. In subgroup analyses, particulate (PNC, , , , and ) and gaseous (, ) pollutants were positively associated with prevalent DSPN in obese participants, whereas corresponding estimates for nonobese participants were close to the null [e.g., for an IQR increase in PNC, (95% CI: 1.05, 1.31) vs. 1.06 (95% CI: 0.95, 1.19); ]. With the exception of , corresponding associations with incident DSPN were positive in obese participants but null or inverse for nonobese participants, with [e.g., for PNC, (95% CI: 1.08, 1.51) vs. 1.03 (95% CI: 0.90, 1.18); ].Discussion: Both particulate and gaseous air pollutants were positively associated with prevalent and incident DSPN in obese individuals. Obesity and air pollution may have synergistic effects on the development of DSPN. https://doi.org/10.1289/EHP7311 相似文献
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Regina Stegherr Arthur Allignol Reinhard Meister Christof Schaefer Jan Beyersmann 《Statistics in medicine》2020,39(4):481-493
Both delayed study entry (left-truncation) and competing risks are common phenomena in observational time-to-event studies. For example, in studies conducted by Teratology Information Services (TIS) on adverse drug reactions during pregnancy, the natural time scale is gestational age, but women enter the study after time origin and upon contact with the service. Competing risks are present, because an elective termination may be precluded by a spontaneous abortion. If left-truncation is entirely random, the Aalen-Johansen estimator is the canonical estimator of the cumulative incidence functions of the competing events. If the assumption of random left-truncation is in doubt, we propose a new semiparametric estimator of the cumulative incidence function. The dependence between entry time and time-to-event is modeled using a cause-specific Cox proportional hazards model and the marginal (unconditional) estimates are derived via inverse probability weighting arguments. We apply the new estimator to data about coumarin usage during pregnancy. Here, the concern is that the cause-specific hazard of experiencing an induced abortion may depend on the time when seeking advice by a TIS, which also is the time of left-truncation or study entry. While the aims of counseling by a TIS are to reduce the rate of elective terminations based on irrational overestimation of drug risks and to lead to better and safer medical treatment of maternal disease, it is conceivable that women considering an induced abortion are more likely to seek counseling. The new estimator is also evaluated in extensive simulation studies and found preferable compared to the Aalen-Johansen estimator in non–misspecified scenarios and to at least provide for a sensitivity analysis otherwise. 相似文献
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