Category: Statistics

Menopause. 2022 May 1;29(5):580-589. doi: 10.1097/GME.0000000000001944.

ABSTRACT

OBJECTIVE: To compare the impact of micronized progesterone (MP) or medroxyprogesterone acetate (MPA) in combination with transdermal estradiol (t-E2) on traditional coagulation factors and thrombin generation parameters in postmenopausal women diagnosed with premature ovarian insufficiency or early menopause.

METHOD: Randomized prospective trial conducted in women diagnosed with premature ovarian insufficiency or early menopause and an intact uterus, recruited over 28 months. All participants were prescribed t-E2 and randomized to either cyclical MP or MPA using a web-based computer randomization software, Graph Pad. Thrombin generation parameters were measured at baseline and repeated after 3-months. Traditional hemostatic biomarkers were measured at baseline and repeated after 3, 6, and 12-months. Seventy-one participants were screened for the study, of whom 66 met the inclusion criteria. In total, 57 participants were randomized: 44 completed the thrombin generation assessment arm of the study, whilst 32 completed 12-months of the traditional coagulation factor screening component of the trial.

RESULTS: Thrombin generation parameters did not significantly change from baseline after 3-months duration for either progestogen component when combined with t-E2, unlike the traditional coagulation factors. Protein C activity, free Protein S, and Antithrombin III levels decreased with time in both treatment arms.

CONCLUSION: Fluctuations in traditional hemostatic biomarkers were not reproduced by parallel changes in thrombin generation parameters that remained neutral in both groups compared with baseline. The absence of statistically significant changes in thrombin generation for the first 3-months of hormone therapy use is reassuring and would suggest a neutral effect of both progestogens on the global coagulation assay.

PMID:35486948 | DOI:10.1097/GME.0000000000001944

Nicotine Tob Res. 2022 Apr 29:ntac115. doi: 10.1093/ntr/ntac115. Online ahead of print.

ABSTRACT

INTRODUCTION: We calculate the U.S. adult smoking cessation rate for 2014-2019, compare it to the historical trend, and estimate the implication for future smoking prevalence.

METHODS: We repeated an earlier analysis, which examined the cessation rate from 1990-2014, extending the period to 2019. Employing National Health Interview Survey (NHIS) and National Survey on Drug Use and Health (NSDUH) data, we estimated the adult cessation rate in six-year intervals, using weighted non-linear least squares. We then employed a meta-regression model to test whether the cessation rate has increased beyond expectation. We used cessation rate estimates and smoking initiation rate estimates to project smoking prevalence in 2030 and eventual steady-state prevalence.

RESULTS: The annual cessation rate increased 29% using NHIS data (from 4.2% in 2008-2013 to 5.4% in 2014-2019) and 33% with NSDUH data (4.2% to 5.6%). The cessation rate increase accounts for 60% of a smoking prevalence decline in the most recent period exceeding the 1990-2013 predicted trend. The remaining 40% owes to declining smoking initiation. With current initiation and cessation rates, smoking prevalence should fall to 8.3% in 2030 and eventually reach a steady state of 3.53%.

CONCLUSIONS: The smoking cessation rate continued to increase during 2014-2019. NHIS and NSDUH results are practically identical. The larger share (60%) of the smoking prevalence decrease, beyond expectation, attributable to the increased cessation rate is encouraging since the positive health effects of cessation occur much sooner than those derived from declining initiation.

IMPLICATIONS: The smoking cessation rate in the U.S. continues to increase, accelerating the decline in smoking prevalence. This increase suggests that the Healthy People 2030 goal of 5% adult smoking prevalence, while ambitious, is attainable. Our findings can be used in simulation and statistical models that aim to predict future prevalence and population health effects due to smoking under various scenarios.

PMID:35486922 | DOI:10.1093/ntr/ntac115

J Hosp Palliat Nurs. 2022 Jun 1;24(3):167-174. doi: 10.1097/NJH.0000000000000845. Epub 2022 Feb 11.

ABSTRACT

The need for hospice care is increasing in the United States, but insufficient lengths of stay and disparity in access to care continue. Few studies have examined the relationship between the presence of symptoms and hospice referral. The study measured the association between hospice referral and demographic characteristics and the presence of pain and depression in a cohort of people hospitalized with metastatic cancer in New Jersey in 2018. This study was secondary analysis of the 2018 New Jersey State Inpatient Database. The sample was limited to adult patients with metastatic cancer. Descriptive statistics evaluated the composition of the sample. Generalized linear modeling estimated the effect of pain and depression on incidence of hospice referral in a racially and economically diverse population. Absence of pain resulted in lower odds of receiving a referral to hospice upon discharge (adjusted odds ratio [AOR], 0.44; 95% confidence interval [CI], 0.40-0.49; P = .00). Likewise, an absence of depression also resulted in decreased odds of a hospice referral (AOR, 0.85; 95% CI, 0.76-0.96; P = .008). Compared with Whites, Blacks (AOR, 0.86; 95% CI, 0.76-0.97; P = .00) and Hispanics had significantly lower odds of receiving a hospice referral (AOR, 0.84; 95% CI, 0.72-0.96; P = .01). Patients with a primary language other than English, there were significantly lower odds of receiving a hospice referral (AOR, 0.85; 95% CI, 0.73-0.99; P = .03). Patients with pain and depression had increased hospice referrals. Disparities persist in hospice referral, particularly in Black and Hispanic cases and those without a primary language of English.

PMID:35486912 | DOI:10.1097/NJH.0000000000000845

JMIR Perioper Med. 2022 Apr 29. doi: 10.2196/29045. Online ahead of print.

ABSTRACT

BACKGROUND: At the height of COVID 19 pandemic, the hepato-pancreato-biliary (HPB) unit had to reorganize surgical case volume due to rationing of healthcare resources. We report local audit evaluating the impact of COVID-19 on the HPB unit and its impact on HPB surgical oncology practice.

OBJECTIVE: The primary measure of the study was to review the impact of the COVID 19 pandemic on the HPB unit’s elective and emergency surgical cases. Secondary measures were to investigate the impact on HPB surgical oncology operative case volume.

METHODS: We performed a comparative audit of the HPB unit surgical case volume for January-June 2019 (baseline) and 2020 (COVID-19). Elective and emergency cases performed under general anesthesia were audited. Elective cases included hernia, gallbladder surgeries, liver and pancreatic resections. Emergency cases included cholecystectomies and laparotomies performed for general surgical indications. We excluded endoscopy and procedures done under local anaesthesia. The retrospective data collected in the two time periods were compared. The study was registered with the Chinese Clinical Trial Registry (ChiCTR2000040265).

RESULTS: Elective surgical case volume decreased by 41.8% (n=351 (2019) vs. 204 (2020)) during the COVID-19 pandemic. Hernia surgery decreased by 63.9% (n=155 (2019) vs. 56 (2020), P=<.001) and cholecystectomy by 40.1% (n=157 (2019) vs. 94 (2020), P=.826). Liver and pancreatic resection volume increased by 16.7% (n=30 (2019) vs. 35 (2020), P=.004) and 111.1% (n=9 (2019) vs. 19 (2020), P=.001). The emergency surgical workload reduced by 40.9% (n=193 (2019) vs. 114 (2020)). The most significant reduction in emergency workload was observed in March, 41 to 23 cases (43.9%, P=.94), April 35 to 8 cases (77.1%, P =.01), and May 32 to 14 cases (56.3%, P=.39), however only April month showed statistically significant reduction in workload (P=.01).

CONCLUSIONS: Reallocation of resources due to the COVID-19 pandemic did not adversely impact elective HPB oncology work. With prudent measures in place, essential surgical services can be maintained during a pandemic.

CLINICALTRIAL: Chinese Clinical Trial Registry (ChiCTR2000040265).

PMID:35486909 | DOI:10.2196/29045

Med Teach. 2022 Apr 29:1-8. doi: 10.1080/0142159X.2022.2064736. Online ahead of print.

ABSTRACT

CONTEXT: In Team Based Learning (TBL), it is, based on theory, assumed that knowledge development in each phase contributes to the subsequent phase and to learning performance. However, there is no empirical evidence for this assumption.

AIM: In order to find support for the relation between TBL and the underlying theory, we determined to what extent each phase of TBL is associated with the knowledge development in the next phase and with the total learning performance.

METHODS: We measured the scientific concepts recalled by 56 second-year undergraduate medical students before TBL, after each of the three phases and after TBL. We used multivariate regression analysis to determine the statistical association between the phases as well as the total learning performance.

RESULTS: Results showed that in each phase, students produced new concepts in addition to those previously recalled. Regression models showed statistically significant explained variance ranging from 0.19 to 0.26, between the three phases and the total learning performance.

DISCUSSION: Each phase of the TBL is significantly associated with knowledge development in the subsequent phase and with the total learning performance, and therefore matters. This study contributes to the scientific underpinning of TBL and offers leads to more elaborate research and interventions to improve TBL.

PMID:35486870 | DOI:10.1080/0142159X.2022.2064736

JMIR Diabetes. 2022 Apr 20. doi: 10.2196/36181. Online ahead of print.

ABSTRACT

BACKGROUND: Lockdown restrictions reduce COVID-19 community transmission; however, they may pose challenges for non-communicable disease management. A 112-day hard lockdown in Victoria, Australia (commencing March 23, 2020), coincided with an intervention trial of reducing and breaking up sitting time in desk workers with type 2 diabetes who were using a provided consumer grade activity tracker (Fitbit).

OBJECTIVE: To compare continuously recorded activity levels preceding and during COVID-19 lockdown restrictions among working adults with type 2 diabetes participating in a sitting less and moving more intervention.

METHODS: Eleven participants (8/11 male; mean [SD] age 52.8 [5.0] years) in Melbourne, Australia had Fitbit activity tracked before (mean [SD]: 122.7 [47.9] days) and during (99.7 [62.5] days) city-wide COVID-19 lockdown restrictions. Regression models compared device (Fitbit Inspire HR)-derived activity (steps; METs [metabolic equivalents], mean time in sedentary, lightly, fairly, and very active minutes, and usual bout durations) during restrictions, to pre-restriction. Changes in activity were statistically significant when estimates (Δ%) did not intercept zero.

RESULTS: Overall, there was a decrease in mean: steps (-1,584 steps/day; Δ% : 9%; 95%CI: -11, -7); METs (-83 METs/day; Δ% : -5%; 95%CI: -6, -5); and, lightly active (Δ% : -4%; 95%CI: -8, -1), fairly active (Δ% : -8%; 95%CI: -21, -15), and very active (Δ% : -8%; 95%CI: -11, -5) intensity minutes per day, and increases in mean sedentary minutes per day (+51 mins/day; Δ% : +3%; 95%CI: 1, 6). Only very active (+5.1 mins) and sedentary (+4.3 mins) bout durations changed significantly.

CONCLUSIONS: In a convenience sample of adults with type 2 diabetes, COVID-19 lockdown restrictions were associated with decreases in overall activity levels and increases in very active and sedentary bout durations. A Fitbit monitor provided meaningful continuous long-term data in this context.

CLINICALTRIAL: Australian New Zealand Clinical Trials Registry ANZCTRN12618001159246.

PMID:35486904 | DOI:10.2196/36181

Stat Med. 2022 Apr 29. doi: 10.1002/sim.9419. Online ahead of print.

ABSTRACT

The Finkelstein and Schoenfeld (FS) test is a popular generalized pairwise comparison approach to analyze prioritized composite endpoints (eg, components are assessed in order of clinical importance). Power and sample size estimation for the FS test, however, are generally done via simulation studies. This simulation approach can be extremely computationally burdensome, compounded by increasing number of composite endpoints and with increasing sample size. Here we propose an analytical solution to calculate power and sample size for commonly encountered two-component hierarchical composite endpoints. The power formulas are derived assuming underlying distributions in each of the component outcomes on the population level, which provide a computationally efficient and practical alternative to the standard simulation approach. Monte Carlo simulation results demonstrate that performance of the proposed power formulas are consistent with that of the simulation approach, and have generally desirable objective properties including robustness to mis-specified distributional assumptions. We demonstrate the application of the proposed formulas by calculating power and sample size for the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial.

PMID:35486817 | DOI:10.1002/sim.9419

Cannabis Cannabinoid Res. 2022 Apr 29. doi: 10.1089/can.2021.0193. Online ahead of print.

ABSTRACT

Background: Synthetic cannabinoids (SCs) users appeared to have heightened risk for cardiac arrhythmias; however, current line of research is insufficient in terms of demonstrating both conventional and novel electrocardiographic arrhythmia risk indicators in this population. Objective(s): We aimed to investigate P-wave dispersion (Pwd), corrected QT interval (QTc), QTc dispersion (QTcd), T_peak-T_end (Tp-e), Tp-e/QT ratio, corrected JT interval (JTc), and JTc dispersion (JTcd), which are shown among the risk factors for emergence of an arrhythmia, among SCs users, suggestive of possible adverse effects of SCs on the cardiac rhythm. Methods: Forty-one male SCs user patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance use disorder criteria and 41 healthy male controls included in the study. Substance-related characteristics were recorded. Electrocardiography recordings under standardized procedure of all participants were performed and arrhythmia risk markers were calculated from electrocardiograms (ECGs). Results: Age and heart rate per minute did not significantly differ between the groups. SCs user group had significantly higher Pwd, QTc, QTcd, Tp-e, Tp-e/QTc ratio, JTc, and JTcd values compared with controls. Among risk markers, only Pwd was significantly correlated with duration of SCs use. Conclusions: Alterations in ECG-derived markers of arrhythmia, which are acquired through an easy and cheap method, should be evaluated for the prediction and prevention of severe cardiac conditions in patients with SCs use.

PMID:35486856 | DOI:10.1089/can.2021.0193

JMIR Public Health Surveill. 2022 Apr 26. doi: 10.2196/34438. Online ahead of print.

ABSTRACT

BACKGROUND: The Surveillance Outbreak Response Management and Analysis System (SORMAS) contains a management module to support countries in epidemic response. It consists of documentation, linkage, and follow-up of cases, contacts, and events. To allow SORMAS users to visualise data, compute essential surveillance indicators, and estimate epidemiological parameters from such network data in real-time, we developed the SORMAS Statistics (SORMAS-Stats) application.

OBJECTIVE: This study aims to describe the essential visualisations, surveillance indicators, and epidemiological parameters implemented in the SORMAS-Stats application and illustrates the application of SORMAS-Stats in response to the COVID-19 outbreak.

METHODS: Based on findings from a rapid review and SORMAS user requests, we included the following visualisation and estimation of parameters in SORMAS-Stats: transmission network diagram, serial interval (SI), time-varying reproduction number R(t), dispersion parameter (k) and additional surveillance indicators presented in graphs and tables. We estimated SI by fitting lognormal, gamma, and Weibull distributions to the observed distribution of the number of days between symptom onset dates of infector-infectee pairs. We estimated k by fitting a negative binomial distribution to the observed number of infectees per infector. Furthermore, we applied the Markov Chain Monte Carlo approach and estimated R(t) using the incidence data and the observed SI computed from the transmission network data.

RESULTS: Using COVID-19 contact-tracing data of confirmed cases reported between July 31 and October 29, 2021, in the Bourgogne-Franche-Comté region of France, we constructed a network diagram containing 63570 nodes. The network comprises 1.75% (1115/63570) events, 19.59% (12452/63570) case persons, and 78.66% (50003/63570) exposed persons, 1238 infector-infectee pairs, 3860 transmission chains with 24.69% (953/3860) having events as the index infector. The distribution with the best fit to the observed SI data was lognormal distribution with a mean of 4.30 days (95% CI, 4.09-4.51 days). We estimated the dispersion parameter k of 21.11 (95% CI, 7.57-34.66) and an effective reproduction number R of 0.9 (95% CI, 0.58-0.60). The weekly estimated R(t) values ranged from 0.80 to 1.61.

CONCLUSIONS: We provide an application for real-time estimation of epidemiological parameters, essential for informing outbreak response strategies. The estimates are commensurate with findings from previous studies. SORMAS-Stats application would greatly assist public health authorities in the regions using SORMAS or similar tools by providing extensive visualisations and computation of surveillance indicators.

PMID:35486812 | DOI:10.2196/34438

Opt Lett. 2022 May 1;47(9):2194-2197. doi: 10.1364/OL.457314.

ABSTRACT

In this Letter, we have proposed an optically levitated conveyor belt based on periodic arrays of a polarization-dependent nanoslit-based metasurface lens (NBML) that is capable of realizing far-field capture, transport, and sorting. The NBML in arrays can be lit up in a relay way by rotating the polarization angle of the excitation beam and thereby provide a better stiffness for transporting particles. When excited at the wavelength of 1064 nm and power density of 0.3 mW/µm², the particles will follow the directional movement of hot spots with an alternative switch of polarization angle and the success ratio of transport can be up to 97.0% with the consideration of Brownian motion. Furthermore, the influence of polarization switching time and incident optical power densities on the efficiency of transport are investigated numerically from a statistical point of view. The sorting of particles with different sizes has also been proved in a given power density. With the analysis of numerical results, our research provides a new approach, to the best of our knowledge, for particle trapping and transport, which is beneficial to on-chip optofluidic applications.

PMID:35486758 | DOI:10.1364/OL.457314