Nevin Manimala

Hosp Pharm. 2023 Feb;58(1):84-91. doi: 10.1177/00185787221122656. Epub 2022 Sep 4.

ABSTRACT

OBJECTIVE: To describe the current prescribing practices of direct oral anticoagulants (DOACs) in intensive care unit (ICU) patients and the associated clinical outcomes, including the incidence of major bleeding episodes and the need for intervention (endoscopic, surgical, or interventional radiology guided).

DESIGN: Observational, retrospective chart review.

SETTING AND PARTICIPANTS: Single large academic center study. Participants included patients with critical illness who were admitted to the intensive care units (ICU) at Mayo Clinic from January 1st, 2012, until May 4th, 2018. Adult ICU patients with a DOAC (apixaban, rivaroxaban, dabigatran, or edoxaban) listed as one of the active medications at the time of hospital admission were included.

RESULTS: 37 249 patients in medical and surgical intensive care units were screened for the study period. After excluding patients who did not qualify, 558 unique encounters were included. The median age was 69 (IQR 59-78) years; most patients were male, white Caucasians, and had a median SOFA score of 4. After excluding the patients who had major bleeding episodes in the first 24 hours, 188 (39%) were continued on the same DOAC therapy, 204 (42%) were discontinued without transitioning to another agent, and 95 (20%) were transitioned to another agent. Finally, 410 (84%) were dismissed on DOAC therapy at the end of hospitalization. The difference in the continuation rate of the same DOAC agent beyond 24 hours, discontinuation without transition to an alternate agent, or discontinuation of DOAC with a transition to an alternate anticoagulation agent was not statistically significant (P = .60). A total of 52 major bleeding events were identified. Gastrointestinal bleeding was the most common bleeding complication [n (%): 34 (65)], followed by intra-abdominal and peri-procedural bleeding [7 (13.5) and 7 (13.5)]. Thirty-three (65%) patients had a major bleeding complication requiring intervention.

CONCLUSIONS: Our single-center retrospective study describes the current prescribing practices and preliminary outcomes in ICU patients with prehospital use of DOACs. Up to 20% of the patients were transitioned to a different agent within 24 hours of ICU admission, whereas a significant proportion of patients (42%) had anticoagulation discontinued altogether. Most patients who suffered a major bleeding episode required either endoscopic or surgical intervention to control bleeding.

PMID:36644754 | PMC:PMC9837329 | DOI:10.1177/00185787221122656

Biom J. 2023 Jan 15:e2200095. doi: 10.1002/bimj.202200095. Online ahead of print.

ABSTRACT

Statistical simulation studies are becoming increasingly popular to demonstrate the performance or superiority of new computational procedures and algorithms. Despite this status quo, previous surveys of the literature have shown that the reporting of statistical simulation studies often lacks relevant information and structure. The latter applies in particular to Bayesian simulation studies, and in this paper the Bayesian simulation study framework (BASIS) is presented as a step towards improving the situation. The BASIS framework provides a structured skeleton for planning, coding, executing, analyzing, and reporting Bayesian simulation studies in biometrical research and computational statistics. It encompasses various features of previous proposals and recommendations in the methodological literature and aims to promote neutral comparison studies in statistical research. Computational aspects covered in the BASIS include algorithmic choices, Markov-chain-Monte-Carlo convergence diagnostics, sensitivity analyses, and Monte Carlo standard error calculations for Bayesian simulation studies. Although the BASIS framework focuses primarily on methodological research, it also provides useful guidance for researchers who rely on the results of Bayesian simulation studies or analyses, as current state-of-the-art guidelines for Bayesian analyses are incorporated into the BASIS.

PMID:36642811 | DOI:10.1002/bimj.202200095

Biom J. 2023 Jan 15:e2100386. doi: 10.1002/bimj.202100386. Online ahead of print.

ABSTRACT

Model-based geostatistical design involves the selection of locations to collect data to minimize an expected loss function over a set of all possible locations. The loss function is specified to reflect the aim of data collection, which, for geostatistical studies, could be to minimize the prediction uncertainty at unobserved locations. In this paper, we propose a new approach to design such studies via a loss function derived through considering the entropy about the model predictions and the parameters of the model. The approach includes a multivariate extension to generalized linear spatial models, and thus can be used to design experiments with more than one response. Unfortunately, evaluating our proposed loss function is computationally expensive so we provide an approximation such that our approach can be adopted to design realistically sized geostatistical studies. This is demonstrated through a simulated study and through designing an air quality monitoring program in Queensland, Australia. The results show that our designs remain highly efficient in achieving each experimental objective individually, providing an ideal compromise between the two objectives. Accordingly, we advocate that our approach could be adopted more generally in model-based geostatistical design.

PMID:36642810 | DOI:10.1002/bimj.202100386

Biom J. 2023 Jan 15:e2200021. doi: 10.1002/bimj.202200021. Online ahead of print.

ABSTRACT

In practice, a disease process might involve three ordinal diagnostic stages: the normal healthy stage, the early stage of the disease, and the stage of full development of the disease. Early detection is critical for some diseases since it often means an optimal time window for therapeutic treatments of the diseases. In this study, we propose a new influence function-based empirical likelihood method and Bayesian empirical likelihood methods to construct confidence/credible intervals for the sensitivity of a test to patients in the early diseased stage given a specificity and a sensitivity of the test to patients in the fully diseased stage. Numerical studies are performed to compare the finite sample performances of the proposed approaches with existing methods. The proposed methods are shown to outperform existing methods in terms of coverage probability. A real dataset from the Alzheimer’s Disease Neuroimaging Initiative (ANDI) is used to illustrate the proposed methods.

PMID:36642803 | DOI:10.1002/bimj.202200021

Biom J. 2023 Jan 15:e2200102. doi: 10.1002/bimj.202200102. Online ahead of print.

ABSTRACT

When comparing the performance of two or more competing tests, simulation studies commonly focus on statistical power. However, if the size of the tests being compared are either different from one another or from the nominal size, comparing tests based on power alone may be misleading. By analogy with diagnostic accuracy studies, we introduce relative positive and negative likelihood ratios to factor in both power and size in the comparison of multiple tests. We derive sample size formulas for a comparative simulation study. As an example, we compared the performance of six statistical tests for small-study effects in meta-analyses of randomized controlled trials: Begg’s rank correlation, Egger’s regression, Schwarzer’s method for sparse data, the trim-and-fill method, the arcsine-Thompson test, and Lin and Chu’s combined test. We illustrate that comparing power alone, or power adjusted or penalized for size, can be misleading, and how the proposed likelihood ratio approach enables accurate comparison of the trade-off between power and size between competing tests.

PMID:36642800 | DOI:10.1002/bimj.202200102

J Genet Couns. 2023 Jan 15. doi: 10.1002/jgc4.1670. Online ahead of print.

ABSTRACT

A growing percentage of genetic counselors are employed in roles that do not involve direct patient care, commonly in commercial diagnostic laboratories. This study aimed to assess characteristics of laboratory and industry (LI) roles and perceptions of the genetic counseling community’s views towards such roles. Members of NSGC and ABGC were invited to participate in this study. Data analysis included descriptive and inferential statistics and select participant quotes are included to highlight key points identified by statistical analyses. Three hundred twenty-six genetic counselors who self-identified as currently or previously working within an LI role responded to the survey. Over 40% of participants reported feeling that they were not perceived positively by colleagues outside of LI settings, and 54% felt that GC colleagues in non-LI roles provided mostly negative commentary about LI GC roles. Over 90% of individuals felt that their employer was a factor in the way they were perceived by others and that this factor carried a bigger weight than job title, work setting, or even professional responsibilities. Qualitative responses from open-ended text questions suggest that while perceptions toward LI roles have improved over time, commentary regarding the “dark side” of genetic counseling persists. To promote the continued, unified growth of the genetic counseling profession and other healthcare professions, it is necessary to address this source of intra-professional conflict.

PMID:36642782 | DOI:10.1002/jgc4.1670

Drug Saf. 2023 Jan 16. doi: 10.1007/s40264-022-01267-z. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVE: Receipt of opioid agonist treatment during early and late pregnancy for opioid use disorder may relate to varying perinatal risks. We aimed to assess the effect of time-varying prenatal exposure to opioid agonist treatment using buprenorphine or methadone on adverse neonatal and pregnancy outcomes.

METHODS: We conducted a retrospective cohort study of pregnant women with opioid use disorder using Rhode Island Medicaid claims data and vital statistics during 2008-16. Time-varying exposure was evaluated in early (0-20 weeks) and late (≥ 21 weeks) pregnancy. Marginal structural models with inverse probability of treatment weighting were applied.

RESULTS: Of 400 eligible pregnancies, 85 and 137 individuals received buprenorphine and methadone, respectively, during early pregnancy. Compared with 152 untreated pregnancies with opioid use disorders, methadone exposure in both periods was associated with an increased risk of preterm birth (adjusted odds ratio [aOR]: 2.52; 95% confidence interval [CI] 1.07-5.95), low birth weight (aOR: 2.99; 95% CI 1.34-6.66), neonatal intensive care unit admission (aOR, 5.04; 95% CI 2.49-10.21), neonatal abstinence syndrome (aOR: 11.36; 95% CI 5.65-22.82), respiratory symptoms (aOR, 2.71; 95% CI 1.17-6.24), and maternal hospital stay > 7 days (aOR, 14.51; 95% CI 7.23-29.12). Similar patterns emerged for buprenorphine regarding neonatal abstinence syndrome (aOR: 10.27; 95% CI 4.91-21.47) and extended maternal hospital stay (aOR: 3.84; 95% CI 1.83-8.07). However, differences were found favoring the use of buprenorphine for preterm birth versus untreated pregnancies (aOR: 0.17; 95% CI 0.04-0.77), and for several outcomes versus methadone.

CONCLUSIONS: Methadone and buprenorphine prescribed for the treatment of opioid use disorder during pregnancy are associated with varying perinatal risks. However, buprenorphine may be preferred in the setting of pregnancy opioid agonist treatment. Further research is necessary to confirm our findings and minimize residual confounding.

PMID:36642778 | DOI:10.1007/s40264-022-01267-z

Environ Sci Pollut Res Int. 2023 Jan 16. doi: 10.1007/s11356-023-25175-6. Online ahead of print.

ABSTRACT

The energy green consumption revolution (EGCR) is the highest priority in the Chinese government’s energy revolution agenda. The purpose of this study is to provide a comprehensive and objective evaluation of the China’s EGCR progressing from 2011 to 2019. In this study, an integrated economic-social-energy-environmental EGCR evaluation framework is built, and the entropy-weighted TOPSIS method with four customized equations is used to calculate and analyze the EGCR index. The study finds that the EGCR index at the national level fluctuates between 0.290 and 0.302, showing a stagnant and regressive trend. At the regional and provincial levels, the EGCR index for eastern China remains at high level, floating above 0.4 and no further growing trend has been indicated. As for the eastern China, Beijing is the only city has high-level EGCR index and is able to maintain positive growth trend. The EGCR index in central, western, and northeastern China is at a low level, fluctuating below 0.4. This result is mainly caused by the fact that the majority of these regions are still constrained by the fossil fuel-dominated social, economy, energy, and environment structures. Therefore, the research findings not only provide supportive evidence for the Chinese government to recognize the progressing of EGCR, but also offer statistical basis over formulating and updating EGCR policies at a timely manner.

PMID:36642773 | DOI:10.1007/s11356-023-25175-6

Skeletal Radiol. 2023 Jan 16. doi: 10.1007/s00256-023-04281-z. Online ahead of print.

ABSTRACT

OBJECTIVE: The accessory sacroiliac joint (ASIJ) is the most common sacroiliac joint anatomical variant; however, its literature-reported prevalence is inconsistent. Previous CT-based studies of the ASIJ have used thick axial slices, which may not adequately detail ASIJ anatomy. The aims of this study are to (1) evaluate ASIJ prevalence and radiographic features in a large age- and sex-balanced cohort using thin-section CT and (2) determine associations between ASIJ anatomy, patient features, and treatment strategies.

MATERIALS AND METHODS: Thin-section CTs (0.75 to 2.00 mm) of the pelvis from 800 patients were reviewed by two musculoskeletal radiologists. Degree of degenerative change and ankylosis at ASIJs were detailed. The EMR was used to capture demographics, lower back or sacroiliac joint symptoms, and treatments.

RESULTS: The ASIJ was present in 25.8% of patients and bilateral in 53.3% of those with any ASIJ. ASIJs were more common at the S2 than S1 neural foramen level (75.7% and 27.2%). There was a statistically significant difference between age and presence of any ASIJ anatomy (mean (SD) 69.0 (19.8) with ASIJ versus 55.9 (22.1) years without ASIJ). Degenerative changes and ankylosis were found in 93.5% and 20.3% of ASIJs, respectively. There was a higher odds ratio of having received a sacroiliac joint corticosteroid injection in those with ASIJ anatomy.

CONCLUSION: Radiologists should be familiar with the ASIJ and consider its age-related association, propensity to show ASIJ degenerative change, and ability to serve as a potential pain generator. Steroid injections may be considered for diagnostic and therapeutic purposes.

PMID:36642769 | DOI:10.1007/s00256-023-04281-z

Int Orthop. 2023 Jan 16. doi: 10.1007/s00264-023-05687-z. Online ahead of print.

ABSTRACT

PURPOSE: The reason for graft failure after anterior cruciate ligament reconstruction (ACLR) is multifactorial. Controversies remain regarding the predominant factor and incidence of failure aetiology in the literature. This review aimed to provide a meta-analysis of the literature to evaluate the relative proportion of various failure modes among patients with ACLR failure.

METHODS: The PubMed, Embase, Cochrane Library, Web of Science, and EBSCO databases were searched for literature on ACLR failure or revision from 1975 to 2021. Data related to causes for ACLR surgical failure were extracted, and a random effects model was used to pool the results, which incorporates potential heterogeneity. Failure modes were compared between different populations, research methods, graft types, femoral portal techniques, and fixation methods by subgroup analysis or linear regression. Funnel plots were used to identify publication bias and small-study effects.

RESULTS: A total of 39 studies were analyzed, including 33 cohort studies and six registry-based studies reporting 6578 failures. The results showed that among patients with ACLR failure or revision, traumatic reinjury was the most common failure mode with a rate of 40% (95% CI: 35-44%), followed by technical error (34%, 95% CI: 28-42%) and biological failure (11%, 95% CI: 7-15%). Femoral tunnel malposition was the most common cause of the technical error (29%, 95% CI: 18-41%), with more than two times higher occurrence than tibial tunnel malposition (11%, 95% CI: 6-16%). Traumatic reinjury was the most common factor for ACLR failure in European populations and in recent studies, while technical errors were more common in Asian populations, earlier studies, and surgery performed using the transtibial (TT) portal technique. Biological factors were more likely to result in ACLR failure in hamstring (HT) autografts compared to bone-patellar tendon-bone (BPTB) autografts.

CONCLUSION: Trauma is the most important factor leading to surgical failure or revision following ACLR. Technical error is also an important contributing factor, with femoral tunnel malposition being the leading cause of error resulting in failure.

PMID:36642768 | DOI:10.1007/s00264-023-05687-z