Who decides what's relevant? Factors driving publication on clinically significant organisms.
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ABSTRACT:
SUBMITTER: Rawlinson S
PROVIDER: S-EPMC8336040 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo ensure the accuracy of susceptibility testing methods for ceftazidime/avibactam.MethodsThe performances of the Etest (bioMérieux), 30/20 μg disc (Hardy diagnostics) and 10/4 μg disc (Mast Group) were evaluated against the reference broth microdilution (BMD) method for 102 clinically relevant Gram-negative organisms: 69 ceftazidime- and meropenem-resistant Klebsiella pneumoniae and 33 MDR non-K. pneumoniae. Essential and categorical agreement along with major and very major error rates were determined according to CLSI guidelines.ResultsA total of 78% of isolates were susceptible to ceftazidime/avibactam. None of the three methods met the defined equivalency threshold against all 102 organisms. The Etest performed the best, with categorical agreement of 95% and major errors of 6.3%. Against the 69 ceftazidime- and meropenem-resistant K. pneumoniae, only the Etest and the 10/4 μg disc met the equivalency threshold. None of the three methods met equivalency for the 33 MDR isolates. There were no very major errors observed in any analysis. These results were pooled with those from a previous study of 74 carbapenem-resistant Enterobacteriaceae and data from the ceftazidime/avibactam new drug application to define optimal 30/20 μg disc thresholds using the error-rate bound model-based approaches of the diffusion breakpoint estimation testing software. This analysis identified a susceptibility threshold of ≤19 mm as optimal.ConclusionsOur data indicate that the Etest is a suitable alternative to BMD for testing ceftazidime/avibactam against ceftazidime- and meropenem-resistant K. pneumoniae. The 30/20 μg discs overestimate resistance and may lead to the use of treatment regimens that are more toxic and less effective.
| S-EPMC6657273 | biostudies-literature
Project description:Benchmark datasets have a powerful normative influence: by determining how the real world is represented in data, they define which problems will first be solved by algorithms built using the datasets and, by extension, who these algorithms will work for. It is desirable for these datasets to serve four functions: (1) enabling the creation of clinically relevant algorithms; (2) facilitating like-for-like comparison of algorithmic performance; (3) ensuring reproducibility of algorithms; (4) asserting a normative influence on the clinical domains and diversity of patients that will potentially benefit from technological advances. Without benchmark datasets that satisfy these functions, it is impossible to address two perennial concerns of clinicians experienced in computational research: "the data scientists just go where the data is rather than where the needs are," and, "yes, but will this work for my patients?" If algorithms are to be developed and applied for the care of patients, then it is prudent for the research community to create benchmark datasets proactively, across specialties. As yet, best practice in this area has not been defined. Broadly speaking, efforts will include design of the dataset; compliance and contracting issues relating to the sharing of sensitive data; enabling access and reuse; and planning for translation of algorithms to the clinical environment. If a deliberate and systematic approach is not followed, not only will the considerable benefits of clinical algorithms fail to be realized, but the potential harms may be regressively incurred across existing gradients of social inequity.
| S-EPMC7305156 | biostudies-literature
Project description:Disenrollment rates are one way that policy makers assess the performance of Medicare Advantage (MA) health plans. We use 3 years of data published by the Centers for Medicare & Medicaid Services (CMS) to examine the characteristics of MA contracts with high disenrollment rates from 2015 to 2017 and the relationship between disenrollment rates in MA contracts and 6 patient experiences of care performance measures. We find that MA contracts with high disenrollment rates were significantly more likely to be for-profit, small, and enroll a greater proportion of low-income and disabled individuals. After adjusting for plan characteristics, contracts with the highest levels of disenrollment were statistically significantly more likely to perform poorly on all 6 patient experience measures. CMS should consider additional oversight of MA contracts with high levels of disenrollment and consider publishing disenrollment rates at the plan level instead of at the contract level.
| S-EPMC6466458 | biostudies-literature
Project description:Pharmaceutical care activities at hospital admission have a significant impact on patient safety. The objective of this study was to identify predictive factors for clinically significant pharmacist interventions (PIs) performed during medication reconciliation and medication review at patient hospital admission.A 4-week prospective study was conducted in 4 medicine wards. At hospital admission, medication reconciliation and medication review were conducted and PIs were performed by the pharmaceutical team. The clinical impact of PIs was determined using the clinical economic and organizational (CLEO) tool. Clinical characteristics, laboratory results, and medication data for each patient were collected and analyzed as potential predictive factors of clinically significant PIs. Univariate and multivariate binary logistic regression were subsequently used to identify independent predictive factors for clinically relevant PIs.Among 265 patients admitted, 150 patients were included. Among 170 PIs performed at hospital admission, 71 were related to unintentional discrepancies (41.8%) during medication reconciliation, and 99 were related to drug-related problems (DRPs) (58.8%) during medication review. Overall, 115 PIs (67.7%) were considered to have a clinical impact. By multivariate analysis, number of medications ?5 (P?=?.01) based on the best possible medication history, and Charlson comorbidity index score ?2 (P?<?.01) were found to be independent predictive factors of clinically significant PIs at hospital admission.Identifying predictive factors of clinically significant PIs is valuable to optimize clinical pharmacist practices at hospital admission during both medication reconciliation and medication review. These 2 steps of the pharmaceutical care process improve medication safety at hospital admission.
| S-EPMC5851721 | biostudies-literature
Project description:ImportanceNo effective treatments are currently available for severe tinnitus, which affects 1% of the population and lowers the quality of life. The factors that contribute to the transition from mild to severe tinnitus are poorly known. Before performing genetic analyses and determining the mechanisms involved in the development of severe tinnitus, its heritability needs to be determined.ObjectivesTo examine whether clinically significant tinnitus is associated with genetic factors and to evaluate the genetic risk in the transmission of tinnitus using adoptees.Design, setting, and participantsData from adoptees and their biological and adoptive parents from Swedish nationwide registers were collected from January 1, 1964, to December 31, 2015, and used to separate genetic from environmental factors in familial clustering. In all, 11 060 adoptees, 19 015 adoptive parents, and 17 025 biological parents were investigated. The study used a cohort design and a case-control approach to study genetic and nongenetic factors in tinnitus among adoptees.Main outcomes and measuresThe primary outcome was odds ratio (OR) of tinnitus in adoptees with at least 1 affected biological parent compared with adoptees without any affected biological parent using logistic regression. The secondary outcome was OR in adoptees with at least 1 affected adoptive parent compared with adoptees without any affected adoptive parent.ResultsA total of 1029 patients (440 [42.8%] male; mean [SD] age, 62 [14] years) with tinnitus were identified. The prevalence of diagnosed tinnitus was 2.2%. The OR for tinnitus was 2.22 for adoptees (95% CI, 1.03-4.81) of biological parents diagnosed with tinnitus, whereas the OR was 1.00 (95% CI, 0.43-2.32) for adoptees from adoptive parents diagnosed with tinnitus. Mean (SE) heritability determined using tetrachoric correlations was 31% (14%).Conclusions and relevanceThe findings suggest that genetic factors are associated with the familial clustering of clinically significant tinnitus with no shared-environment association, revealing that the transition from negligible to severe tinnitus may be associated with genetic factors. These findings may provide insight for future genetic analyses that focus on severe tinnitus.
| S-EPMC6439751 | biostudies-literature
Project description:ObjectiveWe investigate the factors driving the downward trend in employer sponsored health insurance (ESI) coverage between 1999 and 2002 for low- and middle-income workers, and assess their insurance options in the absence of ESI coverage.DataWe use the 1999 and 2002 rounds of the National Survey of America's Families (NSAF), supplemented with ESI premiums from the Medical Expenditure Panel Survey, as well as other state- and county-level data from a variety of sources. The sample includes workers between the ages of 19 and 64.Study designWe first estimate linear probability models of the probability of having an ESI offer and, for those with an offer, the probability of taking up ESI coverage, using two-stage least square regression on the 2002 worker sample. We then use Oaxaca-Blinder regression-based decomposition methods to identify the factors that explain the changes in ESI offer and take-up between 1999 and 2002.Principal findingsWe find that while low-income workers are more likely to be uninsured and are most vulnerable to the loss of ESI coverage, many middle-income workers are also in a precarious position when faced with the loss of ESI coverage. Many low- and middle-income workers have few coverage options in the absence of ESI. This is particularly problematic for low-income workers: only 13 percent have a spouse with an ESI offer and the nongroup premium they face increased at a much higher rate than for middle-income workers. Finally, we find that the drop in ESI offers between 1999 and 2002 was driven largely by changes in nature of the workers' jobs, while the drop in ESI take-up was driven largely by rising ESI premiums.ConclusionsPolicies that shore up the ESI system are important for both low- and middle-income workers, as both are vulnerable to a loss of insurance coverage in the absence of ESI. Over time, the potential coverage options available to low- and middle-income workers in the absence of ESI have narrowed as nongroup premiums have increased. While public coverage has provided some protection from that increase for low-income workers, middle-income workers are much less likely to have access to public protection.
| S-EPMC1955312 | biostudies-literature
Project description:OBJECTIVE:Methadone is associated with prolongation of the electrocardiographic QTc interval. QTc prolongation may be linked to cardiac dysrhythmia and sudden cardiac death. The rate of these events is unknown in methadone-maintained patients. METHODS:This retrospective cohort study of 749 patients with opioid use disorder receiving methadone maintenance therapy through a single safety-net hospital, queried the electronic health record for electrocardiogram results, demographics, methadone dose, and diagnostic codes consistent with cardiac conduction disorder (International Classification of Disease, Ninth Revision [ICD-9] 426) and cardiac dysrhythmia (ICD-9 427). Factors associated with QTc interval were explored; Cox proportional-hazards regression models were used to analyze time to an event that may predispose to sudden cardiac death. RESULTS:One hundred thirty-four patients had an electrocardiogram while on methadone, 404 while off methadone, and 211 both while on and off methadone. Mean QTc interval while on methadone (436?ms, SD 36) was significantly greater than while off methadone (423?ms, SD 33). Age and methadone dose were weakly associated with increased QTc interval (P?<?0.01 and P?<?0.0005, respectively, adjusted R?=?0.05). There were 44 ICD-9 426 and 427 events over 7064 patient-years (6.3?events/1000 patient-yrs). Having a QTc greater than sex-specific cut-off values was significantly associated with time to event (hazard ratio 3.32, 95% confidence interval 1.25-8.81), but being on methadone was not. CONCLUSIONS:Methadone is associated with QTc prolongation in a nonclinically significant dose-related manner. Cardiac events were rare and the sudden cardiac death rate was below that of the general population. Current recommendations for cardiac risk assessment in methadone-maintained patients should be reconsidered.
| S-EPMC5679071 | biostudies-literature
Project description:Healthy hyperplasic (many but smaller fat cells) white adipose tissue (WAT) expansion is mediated by recruitment, proliferation and/or differentiation of new fat cells. This process (adipogenesis) is controlled by transcriptional programs that have been mostly identified in rodents. A systemic investigation of adipogenic human transcription factors (TFs) that are relevant for metabolic conditions has not been revealed previously. TFs regulated in WAT by obesity, adipose morphology, cancer cachexia, and insulin resistance were selected from microarrays. Their role in differentiation of human adipose tissue-derived stem cells (hASC) was investigated by RNA interference (RNAi) screen. Lipid accumulation, cell number, and lipolysis were measured for all screened factors (148 TFs). RNA (RNAseq), protein (Western blot) expression, insulin, and catecholamine responsiveness were examined in hASC following siRNA treatment of selected target TFs. Analysis of TFs regulated by metabolic conditions in human WAT revealed that many of them belong to adipogenesis-regulating pathways. The RNAi screen identified 39 genes that affected fat cell differentiation in vitro, where 11 genes were novel. Of the latter JARID2 stood out as being necessary for formation of healthy fat cell metabolic phenotype by regulating expression of multiple fat cell phenotype-specific genes. This comprehensive RNAi screening in hASC suggests that a large proportion of WAT TFs that are impacted by metabolic conditions might be important for hyperplastic adipose tissue expansion. The screen also identified JARID2 as a novel TF essential for the development of functional adipocytes.
| S-EPMC8197287 | biostudies-literature
Project description:Concerns exist within the medical and psychological sciences that many published research findings are not replicable. Guidelines accordingly recommend that the file drawer effect should be eliminated and that statistical significance should not be a criterion in the decision to submit and publish scientific results. By means of a simulation study, we show that selectively publishing effects that differ significantly from the cumulative meta-analytic effect evokes the Proteus phenomenon of poorly replicable and alternating findings. However, the simulation also shows that the selective publication approach yields a scientific record that is content rich as compared to publishing everything, in the sense that fewer publications are needed for obtaining an accurate meta-analytic estimation of the true effect. We conclude that, under the assumption of self-correcting science, the file drawer effect can be beneficial for the scientific collective.
| S-EPMC3688764 | biostudies-literature
Project description:Background & objectivesThe risk factors for clinically significant diffuse parenchymal lung abnormalities (CS-DPLA) persisting after severe coronavirus disease 2019 (COVID-19) pneumonia remain unclear. The present study was conducted to assess whether COVID-19 severity and other parameters are associated with CS-DPLA.MethodsThe study participants included patients who recovered after acute severe COVID-19 and presented with CS-DPLA at two or six month follow up and control group (without CS-DPLA). Adults volunteers without any acute illness, chronic respiratory illness and without a history of severe COVID-19 were included as healthy controls for the biomarker study. The CS-DPLA was identified as a multidimensional entity involving clinical, radiological and physiological pulmonary abnormalities. The primary exposure was the neutrophil-lymphocyte ratio (NLR). Recorded confounders included age, sex, peak lactate dehydrogenase (LDH), advanced respiratory support (ARS), length of hospital stay (LOS) and others; associations were analyzed using logistic regression. The baseline serum levels of surfactant protein D, cancer antigen 15-3 and transforming growth factor-β (TGF-β) were also compared among cases, controls and healthy volunteers.ResultsWe identified 91/160 (56.9%) and 42/144 (29.2%) participants with CS-DPLA at two and six months, respectively. Univariate analyses revealed associations of NLR, peak LDH, ARS and LOS with CS-DPLA at two months and of NLR and LOS at six months. The NLR was not independently associated with CS-DPLA at either visit. Only LOS independently predicted CS-DPLA at two months [adjusted odds ratios (aOR) (95% confidence interval [CI]), 1.16 (1.07-1.25); P<0.001] and six months [aOR (95% CI) and 1.07 (1.01-1.12); P=0.01]. Participants with CS-DPLA at six months had higher baseline serum TGF-β levels than healthy volunteers.Interpretation and conclusionsLonger hospital stay was observed to be the only independent predictor of CS-DPLA six months after severe COVID-19. Serum TGF-β should be evaluated further as a biomarker.
| S-EPMC10443720 | biostudies-literature