Category: Statistics

Can J Diabetes. 2024 Mar 18:S1499-2671(24)00059-5. doi: 10.1016/j.jcjd.2024.03.003. Online ahead of print.

ABSTRACT

BACKGROUND: No data are available regarding glycemic control of patients with type 1 diabetes mellitus (T1D) during Passover.

OBJECTIVE: To assess the effect of Passover on diabetes management and glycemic control in adults with T1D with nutritional changes during Passover (observant) compared with patients who did not change their dietary habits during Passover (non-observant).

METHODS: Observational pre-post study of adult patients with T1D, followed in a diabetes clinic in Israel. Data were downloaded from insulin pumps and CGM for 37 days: 2 weeks before Passover, 9 days of Passover, and 2 weeks thereafter. Differences in percentage of time spent above target (>10.0 mmol/l and >13.9 mmol/l), at target (3.9-10.0 mmol/l) and below target (<3.9mmol/l and <3.0 mmol/l) were compared using paired t-tests or paired signed rank tests.

RESULTS: The study cohort included 43 patients (23 observant, 20 non-observant). The average BG was significantly higher during Passover compared with the period before Passover – in non-observant patients 8.2±1.5 mmol/l and 7.9±1.3 mmol/l (p=0.043), respectively, and in observant patients 8.7±1.6 mmol/l and 8.4±1.6 mmol/l (p=0.048), respectively. Time above range (TAR) 10-13.9 mmol/l was increased in observant patients during Passover, as compared to the period before Passover – 24.9±16.2% and 20.6±12.4% (p=0.04), respectively. The dose of bolus insulin had increased significantly in observant patients – 27.4±13.9 units during Passover, as compared with 24.2±11.2 units before Passover (p=0.02).

CONCLUSIONS: Passover alters glycemic control and insulin needs in Jewish patients with T1D. It is advisable to make specific adjustments to maintain the recommended glycemic control.

PMID:38508514 | DOI:10.1016/j.jcjd.2024.03.003

J Clin Epidemiol. 2024 Mar 18:111327. doi: 10.1016/j.jclinepi.2024.111327. Online ahead of print.

ABSTRACT

OBJECTIVE: To apply a hierarchical model (HM) that addresses measurement error in regression of the treatment effect on the control group event rate (CR). We compare HM to weighted linear regression (WLR) which is subject to measurement error and mathematical coupling.

STUDY DESIGN AND SETTING: We reviewed published hierarchical models that address measurement error and implemented a Bayesian version in open-source code to facilitate adoption by meta-analysts. We compared WLR and HM across a very large convenience sample of meta-analyses published in the Cochrane Database of Systematic Reviews.

RESULTS: We applied both approaches (WLR and a HM that addresses measurement error) to 3,193 meta-analyses that included 33,071 studies (average 10.28 studies per meta-analysis). A statistically significant slope suggesting an association between the treatment effect and CR was demonstrated with both approaches in 568 (17.19%) meta-analyses, with neither approach in 2,036 (63.77%) meta-analyses, only with WLS in 229 (7.17%) and only with HM in 360 (11.28%) meta-analyses. The majority of slopes were negative (WLR 85%, HM 83%). In the majority of cases, HM had wider confidence intervals (72.53%) and slopes farther from the null (64.77%).

CONCLUSION: Approximately 28% of meta-analyses demonstrate a significant association between the treatment effect and CR when HM is used to address measurement error. User-friendly open-source code is provided to meta-analysts interested in exploring this association.

PMID:38508503 | DOI:10.1016/j.jclinepi.2024.111327

J Neurosci Methods. 2024 Mar 18:110112. doi: 10.1016/j.jneumeth.2024.110112. Online ahead of print.

ABSTRACT

BACKGROUND: Visualizing edges is critical for neuroimaging. For example, edge maps enable quality assurance for the automatic alignment of an image from one modality (or individual) to another.

NEW METHOD: We suggest that using the second derivative (difference of Gaussian, or DoG) provides robust edge detection. This method is tuned by size (which is typically known in neuroimaging) rather than intensity (which is relative).

RESULTS: We demonstrate that this method performs well across a broad range of imaging modalities. The edge contours produced consistently form closed surfaces, whereas alternative methods may generate disconnected lines, introducing potential ambiguity in contiguity.

COMPARISON WITH EXISTING METHODS: Current methods for computing edges are based on either the first derivative of the image (FSL), or a variation of the Canny Edge detection method (AFNI). These methods suffer from two primary limitations. First, the crucial tuning parameter for each of these methods relates to the image intensity. Unfortunately, image intensity is relative for most neuroimaging modalities making the performance of these methods unreliable. Second, these existing approaches do not necessarily generate a closed edge/surface, which can reduce the ability to determine the correspondence between a represented edge and another image.

CONCLUSION: The second derivative is well suited for neuroimaging edge detection. We include this method as part of both the AFNI and FSL software packages, standalone code and online.

PMID:38508496 | DOI:10.1016/j.jneumeth.2024.110112

Top Companion Anim Med. 2024 Mar 18:100862. doi: 10.1016/j.tcam.2024.100862. Online ahead of print.

ABSTRACT

Two studies were developed to compare Borrelia burgdorferi antibody detection between the VetScan Flex4 and SNAP 4Dx Plus tests. The objective of the first study was to evaluate the diagnostic sensitivity (Se) and specificity (Sp) of VetScan Flex4 and SNAP 4Dx Plus B. burgdorferi results using field sourced samples compared to a Western Blot reference method. The sensitivity and specificity of VetScan Flex4 were 81.9% (95% CI: 71.9%-89.5%) and 89.3% (95% CI: 85.2%-92.9%) respectively, and SNAP 4Dx Plus’s sensitivity and specificity were 80.7% (95% CI: 70.6%-88.6%) and 92.8% (95% CI: 89.1%-95.5%) respectively. When comparing VetScan Flex4 and Snap 4Dx Plus, the Simple Kappa Coefficient estimate was 0.76 (95% CI: 0.69-0.84) indicating substantial agreement between the two methods. McNemar’s Test revealed concordance between the two methods was not statistically significant (P = 0.05). The objective of the second study was to evaluate whether VetScan Flex4 differentiates between B. burgdorferi antibodies derived from infection versus vaccination with commonly used canine Lyme vaccines. The sensitivity and specificity of the VetScan Flex4 in differentiating canine Lyme vaccination from infection with Borrelia burgdorferi were 100% (Se 95% CI: 78.2%-100%; Sp 95% CI: 91.2%-100%). In conclusion, the VetScan Flex4 is a reliably sensitive and specific point-of-care test that is similar to Snap 4Dx Plus, can differentiate between infection and Lyme vaccination, and can be utilized by veterinarians for Lyme disease diagnosis and surveillance of B. burgdorferi exposure.

PMID:38508488 | DOI:10.1016/j.tcam.2024.100862

J Affect Disord. 2024 Mar 18:S0165-0327(24)00512-3. doi: 10.1016/j.jad.2024.03.089. Online ahead of print.

ABSTRACT

Exposure and response prevention (ERP) is an evidence-based treatment for obsessive-compulsive disorder (OCD). Theories for how it works vary in their emphasis on active mechanisms of change. The current study aimed to clarify mechanisms of change in ERP for OCD using network analysis, comparing ERP networks at the start and end of intensive treatment (partial hospital and residential). In our sample of 182 patients, the most central node in both networks was engagement with exposure, which was consistently related to greater understanding of ERP rationale, higher willingness, and less ritualization, accounting for all other variables in the network. There were no significant differences in networks between the start and end of treatment. These results suggest that nonspecific parameters like facilitating engagement in exposures without ritualizing and providing a clear rationale to clients may be key to effective treatment. As such, it may be useful for clinicians to spend adequate time underscoring the need to eliminate rituals to fully engage in exposure tasks and explaining the rationale for ERP prior to doing exposures, regardless of theoretical orientation. Nonetheless, findings represent group-level statistics and more fine-grained idiographic analyses may reveal individual-level differences with respect to central mechanisms of change. Other limitations include demographic homogeneity of our sample.

PMID:38508457 | DOI:10.1016/j.jad.2024.03.089

J Affect Disord. 2024 Mar 18:S0165-0327(24)00513-5. doi: 10.1016/j.jad.2024.03.090. Online ahead of print.

ABSTRACT

BACKGROUND: The association between physical multimorbidity and depression differs by populations. However, no direct inter- or intrapopulation comparison of the association has been conducted. Thus, this study aims to estimate the association in China and the United States and reveal inter- and intrapopulation differences in the association.

METHODS: Middle-aged and older adults from the China Health and Retirement Longitudinal Study and the Health and Retirement Study were included. Physical multimorbidity was defined as the simultaneous presence of two or more chronic physical conditions and depressive symptoms was measured by the Center for Epidemiologic Studies Depression Scale. Generalized estimating equation model and stratification multilevel method were the main statistical models.

RESULTS: The presence of physical multimorbidity was associated with a higher risk of depression in both China (RR = 1.360 [95 % CI: 1.325-1.395]) and the US (RR = 1.613 [95 % CI: 1.529-1.701]). For individuals at a low risk of multimorbidity, multimorbidity was associated with 47.4 % (95 % CI: 1.377-1.579) and 71.1 % (95 % CI: 1.412-2.074) increases in the likelihood of depression in China and the US. The effect size was smaller for individuals at a moderate or high risk. However, the cross-national differences were greater for those with a high risk of multimorbidity.

LIMITATIONS: The self-report measures, attribution bias.

CONCLUSIONS: Compared to Chinese adults, the presence of physical multimorbidity led to an additional increase in depressive symptoms for American counterparts. The association was stronger for individuals at a low risk of multimorbidity, but cross-national differences were observed mostly among individuals at a high risk.

PMID:38508455 | DOI:10.1016/j.jad.2024.03.090

Acta Med Port. 2024 Mar 20. doi: 10.20344/amp.19642. Online ahead of print.

ABSTRACT

INTRODUCTION: The COVID-19 pandemic significantly impacted global public health. Infant mortality rate (IMR), a vital statistic and key indicator of a population’s overall health, is essential for developing effective health prevention programs. Existing evidence primarily indicates a decrease in IMR during the COVID-19 pandemic. We conducted a national-level analysis to calculate IMR and describe its course over the years (from 2016 until 2022), using a month-by-month analysis.

METHODS: Data on the number of deaths under one year of age was collected from the Portuguese E-Death Certification System (SICO), and data on the number of monthly live births was obtained from Statistics Portugal. The IMR was calculated per month, considering the previous 12 months’ cumulative number of deaths under one year of age and the number of live births.

RESULTS: In Portugal, the IMR decreased before and during the COVID-19 pandemic. The lowest values were observed in September and October 2021 (2.15 and 2.14 per 1000 live births, respectively). The IMR remained below the threshold of three deaths per 1000 live births during the pandemic’s critical period.

CONCLUSION: Portugal has achieved remarkable progress in reducing its IMR over the last 60 years. The country recorded its lowest-ever IMR values during the COVID-19 pandemic. Further studies are needed to fully understand the observed trends.

PMID:38507776 | DOI:10.20344/amp.19642

N Engl J Med. 2024 Mar 21;390(12):1080-1091. doi: 10.1056/NEJMoa2305488.

ABSTRACT

BACKGROUND: Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear.

METHODS: In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy.

RESULTS: As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P = 0.003). Secondary end points – distant disease-free survival and recurrence-free survival – also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals.

CONCLUSIONS: Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.).

PMID:38507751 | DOI:10.1056/NEJMoa2305488

J Proteome Res. 2024 Mar 20. doi: 10.1021/acs.jproteome.3c00908. Online ahead of print.

ABSTRACT

Proximity-dependent biotinylation (PDB) techniques provide information about the molecular neighborhood of a protein of interest, yielding insights into its function and localization. Here, we assessed how different labeling enzymes and streptavidin resins influence PDB results. We compared the high-confidence interactors of the DNA/RNA-binding protein transactive response DNA-binding protein 43 kDa (TDP-43) identified using either miniTurbo (biotin ligase) or APEX2 (peroxidase) enzymes. We also evaluated two commercial affinity resins for purification of biotinylated proteins: conventional streptavidin sepharose versus a new trypsin-resistant streptavidin conjugated to magnetic resin, which significantly reduces the level of contamination by streptavidin peptides following on-bead trypsin digestion. Downstream analyses involved liquid chromatography coupled to mass spectrometry in data-dependent acquisition mode, database searching, and statistical analysis of high-confidence interactors using SAINTexpress. The APEX2-TDP-43 experiment identified more interactors than miniTurbo-TDP-43, although miniTurbo provided greater overlap with previously documented TDP-43 interactors. Purifications on sepharose resin yielded more interactors than magnetic resin in small-scale experiments using a range of magnetic resin volumes. We suggest that resin-specific background protein binding profiles and different lysate-to-resin ratios cumulatively affect the distributions of prey protein abundance in experimental and control samples, which impact statistical confidence scores. Overall, we highlight key experimental variables to consider for the empirical optimization of PDB experiments.

PMID:38507741 | DOI:10.1021/acs.jproteome.3c00908

Int J STD AIDS. 2024 Mar 20:9564624241239480. doi: 10.1177/09564624241239480. Online ahead of print.

ABSTRACT

BACKGROUND: Heterosexual contact is the primary mode of HIV transmission in China and commercial sex is thought to play a crucial role in China’s epidemic. Female sex workers (FSWs) in China tend to be either brothel-based (BSWs) or street-based (SSWs), but few studies have investigated the differences between these important segments of this difficult-to-reach, high-risk population. Our aim was to explore the differences between SSWs and BSWs in terms of socio-demographic characteristics, sexual and risky practices, HIV/STI-related knowledge, health services, HIV/STI prevalence and other aspects.

METHODS: A cross-sectional survey was conducted in Yunnan Province of China in partnership with a local FSW-friendly non-governmental organization. Face-to-face interviews using a structured questionnaire were conducted to collect data on socio-demographic characteristics, sex work history, sexual behaviours, HIV/STI-related knowledge, HIV testing history, and healthcare services uptake. Blood samples were taken for HIV and syphilis testing, and urine samples for gonorrhea and chlamydia testing. Descriptive statistics were used to evaluate differences between SSWs and BSWs.

RESULTS: A total of 185 BSWs and 129 SSWs were included in the study. SSWs were older and less educated, had more dependents and more clients, lower condom use and accessed fewer healthcare services. Moreover, 37.2% of SSWs and 24.9% of BSWs were found to have HIV/STI infection. Unfortunately, the awareness related to STIs was relatively low in both groups, especially SSWs.

CONCLUSIONS: Our study provides evidence that confirms the disproportionately high vulnerability of SSWs to HIV and other STIs, underscoring the urgent need for the Chinese health and public health sectors to prioritize outreach to SSWs. Awareness and educational programs, condom distribution, testing and health check-ups should be included in a comprehensive strategy for HIV/STI prevention in this high-risk population.

PMID:38507707 | DOI:10.1177/09564624241239480