Tag: statistics

Photobiomodul Photomed Laser Surg. 2023 Oct 27. doi: 10.1089/photob.2023.0021. Online ahead of print.

ABSTRACT

Background: Oral mucositis (OM) is a common adverse effect of radiation to the head and neck. Recent research has shown that extra oral photobiomodulation (EO-PBM) reduces the severity of OM. However, appropriate EO-PBM therapy parameters for OM severity reduction have not been documented. Objective: This work aims to optimize EO-PBM radiation parameters for lowering the severity of radiation-induced OM in rats by establishing a photobiomodulation (PBM) treatment system based on light-emitting diode arrays with top-hat beam profile. Methods: The 36 rats are separated into 2 control groups and 4 groups receiving PBM treatment. The PBM groups are exposed to irradiance between 4 and 24 J/cm² at 660 nm. The cheek pouch mucosa is removed after scarification for biochemical and histological examination. Student’s t-test, and one-way analysis of variance (ANOVA) followed by Tukey’s Multiple were applied to compare the statistical significance of differences between control groups and PBM treatment groups. Results: Statistical analysis reveals that PBM irradiation at 12 J/cm² (200 sec) with a flatness of 0.8 and a diameter of 3 cm substantially decreased the level of inflammatory cytokines compared with the positive control group. Conclusion: Our results indicate that the designed treatment PBM system is capable of delivering the optical parameters necessary for therapeutic treatment.

PMID:37890115 | DOI:10.1089/photob.2023.0021

Diabetes Care. 2023 Nov 1;46(11):2076-2083. doi: 10.2337/dc23-1015.

ABSTRACT

BACKGROUND: Moderate alcohol use may be associated with lower risk of type 2 diabetes mellitus (T2DM). Previous reviews have reached mixed conclusions.

PURPOSE: To quantify the dose-response relationship between alcohol consumption and T2DM, accounting for differential effects by sex and BMI.

DATA SOURCES: Medline, Embase, Web of Science, and one secondary data source.

STUDY SELECTION: Cohort studies on the relationship between alcohol use and T2DM.

DATA EXTRACTION: Fifty-five studies, and one secondary data source, were included with a combined sample size of 1,363,355 men and 1,290,628 women, with 89,983 and 57,974 individuals, respectively, diagnosed with T2DM.

DATA SYNTHESIS: Multivariate dose-response meta-analytic random-effect models were used. For women, a J-shaped relationship was found with a maximum risk reduction of 31% (relative risk [RR] 0.69, 95% CI 0.64-0.74) at an intake of 16 g of pure alcohol per day compared with lifetime abstainers. The protective association ceased above 49 g per day (RR 0.82, 95% CI 0.68-0.99). For men, no statistically significant relationship was identified. When results were stratified by BMI, the protective association was only found in overweight and obese women.

LIMITATIONS: Our analysis relied on aggregate data. We included some articles that determined exposure and cases via self-report, and the studies did not account for temporal variations in alcohol use.

CONCLUSIONS: The observed reduced risk seems to be specific to women in general and women with a BMI ≥25 kg/m2. Our findings allow for a more precise prediction of the sex-specific relationship between T2DM and alcohol use, as our results differ from those of previous studies.

PMID:37890103 | DOI:10.2337/dc23-1015

Br J Surg. 2023 Oct 27:znad336. doi: 10.1093/bjs/znad336. Online ahead of print.

ABSTRACT

BACKGROUND: Breast cancer is the most common cancer worldwide, with remarkable advances in early diagnosis, systemic treatments, and surgical techniques. Robotic nipple-sparing mastectomy has been trialled; however, the complication rates, surgical outcomes, and oncological safety of this approach remain obscure.

METHODS: A systematic search of the literature was conducted from conception until September 2022. Studies examining complications and operative variables where robotic nipple-sparing mastectomy was compared with conventional nipple-sparing mastectomy were included. Primary study outcomes were complications (Clavien-Dindo grade III complications, skin or nipple necrosis, seroma, haematoma, infection, implant loss, and wound dehiscence) and oncological safety (recurrence and positive margins). The secondary outcomes included operative variables, length of stay, cost-effectiveness, learning curve, and aesthetic outcome.

RESULTS: A total of seven studies of overall fair quality, involving 1674 patients, were included in the systematic review and meta-analysis. Grade 3 complications were reduced in robotic nipple-sparing mastectomy without statistical significance (OR 0.60 (95 per cent c.i. 0.35 to 1.05)). Nipple necrosis was significantly reduced in robotic nipple-sparing mastectomy (OR 0.54 (95 per cent c.i. 0.30 to 0.96); P = 0.03; I2 = 15 per cent). Operating time (mean difference +58.81 min (95 per cent c.i. +28.19 to +89.44 min); P = 0.0002) and length of stay (mean difference +1.23 days (95 per cent c.i. +0.64 to +1.81 days); P < 0.0001) were significantly increased in robotic nipple-sparing mastectomy, whereas the opposite was true for blood loss (mean difference -53.18 ml (95 per cent c.i. -71.78 to -34.58 ml); P < 0.0001).

CONCLUSION: Whilst still in its infancy, robotic breast surgery may become a viable option in breast surgery. Nonetheless, the oncological safety of this approach requires robust assessment.

PMID:37890072 | DOI:10.1093/bjs/znad336

Otolaryngol Head Neck Surg. 2023 Oct 27. doi: 10.1002/ohn.567. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the effect of tobacco cessation following laryngeal cancer diagnosis on response to first-line therapy, laryngectomy-free survival, and overall survival in patients who were current smokers at the time of diagnosis.

STUDY DESIGN: Retrospective, case-control study.

SETTING: OU Stephenson Cancer Center, National Cancer Institute-Designated Cancer Center.

METHODS: We included 140 patients diagnosed with laryngeal squamous cell carcinoma, who were current smokers at the time of diagnosis, and were treated with first-line definitive radiation or chemo/radiation with the intent to cure. The association between patient characteristics and treatment response was assessed using the χ² test and logistic regression analysis. Survival outcomes were analyzed using Kaplan-Meier methods and Cox proportional-hazards models.

RESULTS: Of the 140 current smokers, 61 patients (45%) quit smoking prior to treatment initiation. In adjusted logistic regression analysis, quitters had 3.7 times higher odds of achieving a complete response to first-line therapy than active smokers (odds ratio: 3.694 [1.575-8.661]; P = .003). In the adjusted Cox proportional-hazards model, quitters were 54% less likely to require salvage laryngectomy within 7 years of diagnosis than active smokers (hazard ratio: 0.456 [0.246-0.848]; P = .013). Quitters had a statistically significant increase in 7-year overall survival compared to active smokers (P = .02).

CONCLUSION: This is the first study to show that in newly diagnosed laryngeal cancer patients who are current smokers at the time of diagnosis, tobacco cessation significantly increases therapy response, laryngectomy-free survival, and overall survival. These data stress the importance of systematically incorporating tobacco cessation programs into laryngeal cancer treatment plans.

PMID:37890055 | DOI:10.1002/ohn.567

Eur J Prev Cardiol. 2023 Oct 27:zwad340. doi: 10.1093/eurjpc/zwad340. Online ahead of print.

ABSTRACT

BACKGROUND: The triglyceride-glucose (TyG) index has been proposed as an alternative to insulin resistance and as a predictor of cardiovascular outcomes. Little is known on its role in chronic stable cardiovascular disease and its predictive power at controlled low-density lipoprotein (LDL) levels.

METHODS: Our study population consisted of 29,960 participants in the ONTARGET and TRANSCEND trials that enrolled patients with known atherosclerotic disease. Triglycerides and glucose were measured at baseline. TyG was calculated as the logarithmized product of fasting triglycerides and glucose divided by 2. The primary endpoint of both trials was a composite of cardiovascular death, myocardial infarction, stroke or hospitalization for heart failure. The secondary endpoint was all-cause death and the components of the primary endpoint. Cox-proportional hazards models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) with extensive covariate adjustment for demographic, medical history and lifestyle factors.

RESULTS: During a mean follow-up of 4.3 years, 4,895 primary endpoints and 3,571 all-cause deaths occurred. In fully adjusted models, individuals in the highest compared to the lowest quartile of the TyG index were at higher risk for the primary endpoint (HR 1.14; 95% CI 1.05-1.25) and for myocardial infarction (HR 1.30; 95% CI 1.11-1.53). A higher TyG index did not associate with the primary endpoint in individuals with LDL levels <100 mg/dl.

CONCLUSION: A higher TyG index is associated with a modestly increased cardiovascular risk in chronic stable cardiovascular disease. This association is largely attenuated when LDL levels are controlled.Clinical Trial Registration Information – https://www.clinicaltrials.gov; Identifier: NCT00153101.

PMID:37890035 | DOI:10.1093/eurjpc/zwad340

Dis Colon Rectum. 2023 Oct 27. doi: 10.1097/DCR.0000000000003014. Online ahead of print.

ABSTRACT

BACKGROUND: The p value has been criticized for an oversimplified determination of whether a treatment effect exists. One alternative is the fragility index. It is a representation of the minimum number of non-events that would need to be converted to events to increase the p value above 0.05.

OBJECTIVE: To determine the fragility index of randomized controlled trials assessing the efficacy of interventions for patients with diverticular disease since 2010 to assess the robustness of current evidence.

DATA SOURCES: MEDLINE, Embase, and CENTRAL were searched from inception to August 2022.

STUDY SELECTION: Articles were eligible for inclusion if they were randomized trials conducted between 2010 and 2022 with parallel, superiority designs evaluating interventions in patients with diverticular disease. Only randomized trials with dichotomous primary outcomes with an associated p-value of less than 0.05 were considered for inclusion.

INTERVENTIONS: Any surgical or medical intervention for patients with diverticular disease.

MAIN OUTCOME MEASURES: The fragility index was determined by adding events and subtracting non-events from the groups with the smaller number of events. Events were added until the p-value exceeded 0.05. The smallest number of events required was considered the fragility index.

RESULTS: After screening 1,271 citations, 15 randomized trials met inclusion criteria. Nine of the studies evaluated surgical interventions and six evaluated medical interventions. The mean number of patients randomized and lost to follow-up per RCT was 92 (SD 35.3) and 9 (SD 11.4), respectively. The median fragility index was 1 (range: 0-5). The fragility indices for the included studies did not correlate significantly with any study characteristics.

LIMITATIONS: Small sample, heterogeneity, and lack of inclusion of studies with continuous outcomes.

CONCLUSIONS: The randomized trials evaluating surgical and medical interventions for diverticular disease are not robust. Changing a single outcome event in most studies was sufficient to make a statistically significant study finding non-significant.

PMID:37889999 | DOI:10.1097/DCR.0000000000003014

Optom Vis Sci. 2023 Oct 30. doi: 10.1097/OPX.0000000000002078. Online ahead of print.

ABSTRACT

SIGNIFICANCE: This study provides information about the repeatability of Myopia Master and its agreement with Lenstar LS900, which might be useful for the practitioners involved in myopia management.

PURPOSE: Myopia Master is a new optical biometer that measures ocular biometry and refractive error. The purpose of this study is to assess its repeatability (intra-session and short-term inter-session) and its agreement with Lenstar LS900 for the measurement of axial length and corneal curvature.

METHODS: A total of 304 participants including 254 children (Mean age: 13.7 ± 1.6 years) and 50 adults (24 ± 2.9 years) underwent measurements on Myopia Master and Lenstar LS900 to obtain axial length (AL), flat K (K1), and steep K (K2). On a subset of 30 participants, measurements were obtained with Myopia Master in two sessions that were spread over 10 minutes to assess the short-term inter-session repeatability.

RESULTS: The mean standard deviation of Myopia Master in the measurement of axial length in the total sample was 0.01 mm for intra-session, when the best three measurements were considered. The short-term inter-session mean standard deviation for AL, K1, and K2 was 0.06 mm, 0.15 D, and 0.21 D respectively. There were statistically significant differences in mean values of AL (-0.04 ± 0.06 mm), K1 (-0.07 ± 0.15 D), and K2 (-0.24 ± 0.29 D) between Lenstar LS900 and Myopia Master with the Lenstar providing slightly longer axial length and steeper K values. Adults showed better repeatability with Myopia Master and better agreement between the biometers for AL measurement than children. Neither axial length nor refractive error influenced the repeatability or agreement.

CONCLUSIONS: Myopia Master is repeatable for the measurement of axial length and corneal curvature. Considering the differences in axial length between the Myopia Master and Lenstar LS900, caution must be applied when these biometers are used interchangeably.

PMID:37889981 | DOI:10.1097/OPX.0000000000002078

Sci Adv. 2023 Oct 27;9(43):eadg6194. doi: 10.1126/sciadv.adg6194. Epub 2023 Oct 27.

ABSTRACT

An extensive evaluation of disease occurrence after statin use based on a “hypothesis-free” approach remains scarce. To examine the effect of statin use on the potential risk of developing diseases, a propensity score-matched cohort study was executed using data from the National Sample Cohort in South Korea. A total of 7847 statin users and 39,235 nonstatin users were included in the final analysis. The period of statin use was defined as our main time-dependent exposure and was divided into three periods: current, recent, and past. The main outcomes were defined as new-onset diseases with ≥100 events based on the International Statistical Classification of Diseases, 10th Revision. We calculated the adjusted hazard ratios and 95% confidence intervals (CIs) using Cox regression. We found that statin use significantly increased the risk of developing iron deficiency anemia up to 5.04 times (95% CI, 2.11 to 12.03). Therefore, the iron levels of patients using statins should be monitored carefully.

PMID:37889968 | DOI:10.1126/sciadv.adg6194

Chaos. 2023 Oct 1;33(10):103139. doi: 10.1063/5.0165484.

ABSTRACT

Fisher information is a lower bound on the uncertainty in the statistical estimation of classical and quantum mechanical parameters. While some deterministic dynamical systems are not subject to random fluctuations, they do still have a form of uncertainty. Infinitesimal perturbations to the initial conditions can grow exponentially in time, a signature of deterministic chaos. As a measure of this uncertainty, we introduce another classical information, specifically for the deterministic dynamics of isolated, closed, or open classical systems not subject to noise. This classical measure of information is defined with Lyapunov vectors in tangent space, making it less akin to the classical Fisher information and more akin to the quantum Fisher information defined with wavevectors in Hilbert space. Our analysis of the local state space structure and linear stability leads to upper and lower bounds on this information, giving it an interpretation as the net stretching action of the flow. Numerical calculations of this information for illustrative mechanical examples show that it depends directly on the phase space curvature and speed of the flow.

PMID:37889952 | DOI:10.1063/5.0165484

Sex Transm Dis. 2023 Oct 23. doi: 10.1097/OLQ.0000000000001882. Online ahead of print.

ABSTRACT

BACKGROUND: During the 2022 mpox outbreak, most cases were associated with sexual contact and many people with mpox sought care from sexual health clinics and programs. The National Network of STD Clinical Prevention Training Centers (NNPTC), in partnership with Centers for Disease Control and Prevention, conducted a survey of United States sexual health clinics and programs to assess knowledge, practices, and experiences around mpox to inform a future public health response.

METHODS: Between August 31-September 13, 2022, the NNPTC facilitated a web-based survey. Descriptive statistics were generated in R.

RESULTS: Among 168 responses by clinicians (n = 131, 78%) and program staff (n = 37, 22%), more than half (51%) reported at least somewhat significant mpox-related clinical disruptions including burdensome paperwork requirements for mpox testing (40%) and tecovirimat use (88%). Long clinic visits (51%) added additional burden, the median mpox-related visit lasted one hour. Few clinicians felt comfortable with advanced pain management, and clinicians felt most uninformed about pre-exposure (19%) and post-exposure (24%) prophylaxis. Of 89 respondents involved in vaccination, 61% reported using equity strategies; however, accounts of these strategies revealed a focus on guideline or risk factor-based screenings instead of equity activities.

CONCLUSIONS: These findings highlight the substantial impact of the 2022 mpox outbreak on sexual health care in the United States. Critical gaps and barriers were identified that may inform additional mpox training and technical assistance, including challenges with testing, diagnosis, and management as well as a disconnect between programs’ stated goal of equity and operationalization of strategies to achieve equity.

PMID:37889929 | DOI:10.1097/OLQ.0000000000001882