Category: Statistics

J Ethn Subst Abuse. 2023 Jan 12:1-21. doi: 10.1080/15332640.2022.2159911. Online ahead of print.

ABSTRACT

Cigarette smoking is associated with adverse physical and mental health among Latinx adults in the United States. The present investigation sought to explore the main and interactive effects of anxiety symptoms and anxiety sensitivity in relation to cigarette dependence, perceived barriers for smoking cessation, and severity of problems experienced when quitting among adult Latinx smokers. Participants included 338 Latinx adult daily cigarette smokers (M_age = 35.53 years; SD = 8.65; age range 18-61; 37.3% female). Results indicated that anxiety symptoms were associated with greater cigarette dependence, severity of problems when quitting, and perceived barriers for smoking cessation (effect size range: 2%-3% of variance), whereas anxiety sensitivity was related to severity of problems when quitting and perceived barriers for smoking cessation (effect size range: 2%-3% of variance). There was also a statistically significant interaction between anxiety sensitivity and anxiety symptoms for cigarette dependence; anxiety was related to cigarette dependence for Latinx smokers with higher levels of anxiety sensitivity, but not for those with lower levels of anxiety sensitivity. Overall, the present findings indicate that anxiety symptoms and anxiety sensitivity are relevant factors for better understanding cigarette dependence, problems experienced when trying to quit, and perceptions of barriers to quitting among adult Latinx smokers.

PMID:36633880 | DOI:10.1080/15332640.2022.2159911

Comput Inform Nurs. 2022 Oct 14. doi: 10.1097/CIN.0000000000000957. Online ahead of print.

ABSTRACT

Virtual and human patient simulation methods offer an effective way to increase patient safety, reduce the incidence of errors, and improve clinical decision-making skills. The study was conducted to compare the effects of virtual and human patient simulation methods on performance, simulation-based learning, anxiety, and self-confidence with clinical decision-making scores of nursing students. A quasi-experimental, stratified, randomized controlled study was conducted with third-year nursing students. The students (n = 166) were divided into experimental and control groups. The difference between the pretest-posttest scores of intragroup nursing anxiety and self-confidence with clinical decision-making and total and sub-scale scores of in-group simulation-based learning were statistically significant (P < .05). Performance scores were found to be statistically significantly high in the virtual patient simulation group (P < .001). It was determined that virtual patient simulation was superior to other methods in terms of nursing anxiety and self-confidence with clinical decision-making, simulation-based learning, and performance scores.

PMID:36633879 | DOI:10.1097/CIN.0000000000000957

JAMA Ophthalmol. 2023 Jan 12. doi: 10.1001/jamaophthalmol.2022.5817. Online ahead of print.

ABSTRACT

IMPORTANCE: Tractional retinal detachment (TRD) occurs in approximately 5% of people with proliferative diabetic retinopathy and poses a threat to vision. Pars plana vitrectomy (PPV) is the treatment of choice for TRD.

OBJECTIVE: To determine anatomic and functional outcomes of PPV for the treatment of TRD in people with diabetes (dTRD).

DATA SOURCES: MEDLINE and Embase were searched systematically from January 1, 2000, to February 20, 2022. In addition, a reference list of eligible studies were screened.

STUDY SELECTION: Eligible studies were those published in English, those reporting outcomes of PPV for dTRD, and those that included more than 25 eyes and with a minimum follow-up of 3 months.

DATA EXTRACTION AND SYNTHESIS: Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for data extraction/synthesis were followed, and the National Institute for Health quality assessment tool was used to assess risk of bias. Study eligibility was determined independently by 2 reviewers; data extraction was conducted by 1 reviewer and entries checked for accuracy by another. Data were pooled using a random-effects model.

MAIN OUTCOMES AND MEASURES: Main outcomes included rate of failure of retinal reattachment following 1 surgery and final visual acuity (VA). The association of baseline patient characteristics and surgical maneuvers with postoperative surgical outcomes was investigated.

RESULTS: Of the 406 studies identified, 38 (3839 eyes) were eligible and included for analysis. Patients had a median (IQR) age of 52.2 (49.6-55.7) years. In the studies reporting patient sex (31 of 38 studies), 1441 were female individuals (50.1%). The overall failure rate of retinal reattachment after 1 surgery was 5.9% (95% CI, 1.4%-8.3%), and the mean final VA was 0.94 (95% CI, 0.82-1.05) logMAR (approximate Snellen equivalent, 6/53; 95% CI, 6/39-6/71). People with higher preoperative VA achieved higher postoperative vision (0.66 logMAR worse final vision; 95% CI, 0.39-0.84 per 1.0 logMAR worse at baseline; P <.001). On multivariable analysis, no other patient characteristics or surgical variables had a statistically significant association with outcomes.

CONCLUSIONS AND RELEVANCE: Results of this systematic review and meta-analysis suggest that PPV was an effective strategy to achieve retinal reattachment in people with dTRD. Given that higher preoperative VA was the only factor associated with higher postoperative vision, early intervention should be considered and discussed in detail with patients. Overall, final postoperative VA remains low, and patients should be counseled on the guarded prognosis of dTRD.

PMID:36633878 | DOI:10.1001/jamaophthalmol.2022.5817

JAMA Oncol. 2023 Jan 12. doi: 10.1001/jamaoncol.2022.6558. Online ahead of print.

ABSTRACT

IMPORTANCE: Magnetic resonance imaging (MRI) guidance offers multiple theoretical advantages in the context of stereotactic body radiotherapy (SBRT) for prostate cancer. However, to our knowledge, these advantages have yet to be demonstrated in a randomized clinical trial.

OBJECTIVE: To determine whether aggressive margin reduction with MRI guidance significantly reduces acute grade 2 or greater genitourinary (GU) toxic effects after prostate SBRT compared with computed tomography (CT) guidance.

DESIGN, SETTING, AND PARTICIPANTS: This phase 3 randomized clinical trial (MRI-Guided Stereotactic Body Radiotherapy for Prostate Cancer [MIRAGE]) enrolled men aged 18 years or older who were receiving SBRT for clinically localized prostate adenocarcinoma at a single center between May 5, 2020, and October 1, 2021. Data were analyzed from January 15, 2021, through May 15, 2022. All patients had 3 months or more of follow-up.

INTERVENTIONS: Patients were randomized 1:1 to SBRT with CT guidance (control arm) or MRI guidance. Planning margins of 4 mm (CT arm) and 2 mm (MRI arm) were used to deliver 40 Gy in 5 fractions.

MAIN OUTCOMES AND MEASURES: The primary end point was the incidence of acute (≤90 days after SBRT) grade 2 or greater GU toxic effects (using Common Terminology Criteria for Adverse Events, version 4.03 [CTCAE v4.03]). Secondary outcomes included CTCAE v4.03-based gastrointestinal toxic effects and International Prostate Symptom Score (IPSS)-based and Expanded Prostate Cancer Index Composite-26 (EPIC-26)-based outcomes.

RESULTS: Between May 2020 and October 2021, 156 patients were randomized: 77 to CT (median age, 71 years [IQR, 67-77 years]) and 79 to MRI (median age, 71 years [IQR, 68-75 years]). A prespecified interim futility analysis conducted after 100 patients reached 90 or more days after SBRT was performed October 1, 2021, with the sample size reestimated to 154 patients. Thus, the trial was closed to accrual early. The incidence of acute grade 2 or greater GU toxic effects was significantly lower with MRI vs CT guidance (24.4% [95% CI, 15.4%-35.4%] vs 43.4% [95% CI, 32.1%-55.3%]; P = .01), as was the incidence of acute grade 2 or greater gastrointestinal toxic effects (0.0% [95% CI, 0.0%-4.6%] vs 10.5% [95% CI, 4.7%-19.7%]; P = .003). Magnetic resonance imaging guidance was associated with a significantly smaller percentage of patients with a 15-point or greater increase in IPSS at 1 month (6.8% [5 of 72] vs 19.4% [14 of 74]; P = .01) and a significantly reduced percentage of patients with a clinically significant (≥12-point) decrease in EPIC-26 bowel scores (25.0% [17 of 68] vs 50.0% [34 of 68]; P = .001) at 1 month.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, compared with CT-guidance, MRI-guided SBRT significantly reduced both moderate acute physician-scored toxic effects and decrements in patient-reported quality of life. Longer-term follow-up will confirm whether these notable benefits persist.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04384770.

PMID:36633877 | DOI:10.1001/jamaoncol.2022.6558

Transl Vis Sci Technol. 2023 Jan 3;12(1):19. doi: 10.1167/tvst.12.1.19.

ABSTRACT

PURPOSE: A previous study from our research group showed significantly lower levels of RANTES (Regulated upon Activation, Normal T Cell Expressed and Secreted) in patients with intermediate age-related macular degeneration (AMD) compared to control patients with no AMD. The primary aim of this study was to assess levels of RANTES in a cohort of patients with a more advanced form of the disease, geographic atrophy (GA), in comparison with controls.

METHODS: The study was conducted on a cohort of patients with GA recruited into a Colorado AMD registry. Cases and controls were defined with multimodal imaging. Plasma levels of the chemokine RANTES were measured using a multiplex assay. A nonparametric (rank-based) regression model was fit to RANTES with a sex by AMD category interaction.

RESULTS: The plasma levels of RANTES were significantly higher in the control group in comparison to the GA AMD group (median [interquartile range]): 10,204 [5799-19,554] pg/mL vs. 5435 [3420-9177] pg/mL, respectively, P < 0.01). When moderated by sex, there was no statistical difference between the male and female GA AMD or the male and female controls.

CONCLUSIONS: We found lower level of RANTES in patients with GA AMD compared with controls. This finding is consistent with the findings from our previous intermediate AMD study. However, in contrast to the results of our previous research, when moderated by sex there was no statistical difference between male and female GA patients.

TRANSLATIONAL RELEVANCE: The biomarker RANTES is significantly lower in GA AMD patients compared to controls.

PMID:36633873 | DOI:10.1167/tvst.12.1.19

JAMA Oncol. 2023 Jan 12. doi: 10.1001/jamaoncol.2022.6549. Online ahead of print.

ABSTRACT

IMPORTANCE: The risk and timing of suicide among patients who undergo surgery for cancer remain largely unknown, and, to our knowledge, there are currently no organized programs in place to implement regular suicide screening among this patient population.

OBJECTIVE: To evaluate the incidence, timing, and factors associated with suicide among patients undergoing cancer operations.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective population-based cohort study used data from the Surveillance, Epidemiology, and End Results Program database to examine the incidence of suicide, compared with the general US population, and timing of suicide among patients undergoing surgery for the 15 deadliest cancers in the US from 2000 to 2016. A Fine-Gray competing risks regression model was used to identify factors associated with an increased risk of suicide among patients in the cohort. Data were analyzed from September 2021 to January 2022.

EXPOSURES: Surgery for cancer.

MAIN OUTCOMES AND MEASURES: Incidence, compared with the general US population, timing, and factors associated with suicide after surgery for cancer.

RESULTS: From 2000 to 2016, 1 811 397 patients (74.4% female; median [IQR] age, 62.0 [52.0-72.0] years) met study inclusion criteria. Of these patients, 1494 (0.08%) committed suicide after undergoing surgery for cancer. The incidence of suicide, compared with the general US population, was statistically significantly higher among patients undergoing surgery for cancers of the larynx (standardized mortality ratio [SMR], 4.02; 95% CI, 2.67-5.81), oral cavity and pharynx (SMR, 2.43; 95% CI, 1.93-3.03), esophagus (SMR, 2.25; 95% CI, 1.43-3.38), bladder (SMR, 2.09; 95% CI, 1.53-2.78), pancreas (SMR, 2.08; 95% CI, 1.29-3.19), lung (SMR, 1.73; 95% CI, 1.47-2.02), stomach (SMR, 1.70; 95% CI, 1.22-2.31), ovary (SMR, 1.64; 95% CI, 1.13-2.31), brain (SMR, 1.61; 95% CI, 1.12-2.26), and colon and rectum (SMR, 1.28; 95% CI, 1.16-1.40). Approximately 3%, 21%, and 50% of suicides were committed within the first month, first year, and first 3 years after surgery, respectively. Patients who were male, White, and divorced or single were at greatest risk of suicide.

CONCLUSIONS AND RELEVANCE: In this cohort study, the incidence of suicide among patients undergoing cancer operations was statistically significantly elevated compared with the general population, highlighting the need for programs to actively implement regular suicide screening among such patients, especially those whose demographic and tumor characteristics are associated with the highest suicide risk.

PMID:36633854 | DOI:10.1001/jamaoncol.2022.6549

Med Sci Sports Exerc. 2023 Jan 12. doi: 10.1249/MSS.0000000000003123. Online ahead of print.

ABSTRACT

PURPOSE: Harmonization of assessment methods represents an ongoing challenge in physical activity research. Previous research has demonstrated the utility of calibration approaches to enhance agreement between measures of physical activity. The present study utilizes a calibration methodology to add behavioral context from the Global Physical Activity Questionnaire (GPAQ), an established report-based measure, to enhance interpretations of monitor-based data scored using the novel Monitor Independent Movement Summary (MIMS) methodology.

METHODS: Matching data from the GPAQ and MIMS were obtained from adults (20-80 years of age) assessed in the 2011-2014 National Health and Nutrition Examination Survey (NHANES). After developing percentile curves for self-reported activity, a zero-inflated quantile regression model was developed to link MIMS to estimates of moderate to vigorous physical activity (MVPA) from the GPAQ.

RESULTS: Cross validation of the model showed that it closely approximated the probability of reporting MVPA across age and activity level segments, supporting the accuracy of the zero-inflated model component. Validation of the quantile regression component directly corresponded to the 25%, 50% and 75% values for both males and females, further supporting the model fit.

CONCLUSIONS: This study offers a method of improving activity surveillance by translating accelerometer signals into interpretable behavioral measures using nationally representative data. The model provides accurate estimates of minutes of MVPA at a population level but, due to the bias and error inherent in report-based measures of physical activity, is not suitable for converting or interpreting individual level data. This study provides an important preliminary step in utilizing information from both device- and report-based methods to triangulate activity related outcomes; however additional measurement error modeling is needed to improve precision.

PMID:36633833 | DOI:10.1249/MSS.0000000000003123

Drugs Aging. 2023 Jan 12. doi: 10.1007/s40266-022-00994-3. Online ahead of print.

ABSTRACT

The lifetime risk of symptomatic hand osteoarthritis (OA) is 39.8%, with one in two women and one in four men developing the disease by age 85 years and no disease-modifying drug (DMOAD) available so far. Intra-articular (IA) therapy is one of the options commonly used for symptomatic alleviation of OA disease as it can circumvent systemic exposure and potential side effects of oral medications. The current narrative review focuses on the efficacy and safety profiles of the currently available IA agents in hand OA (thumb-base OA or interphalangeal OA) such as corticosteroids and hyaluronic acid (HA), as well as the efficacy and safety of IA investigational injectates in phase 2/3 clinical trials such as prolotherapy, platelet-rich plasma, stem cells, infliximab, interferon-? and botulinum toxin, based on the published randomized controlled trials on PubMed database. The limited published literature revealed the short-term symptomatic benefits of corticosteroids in interphalangeal OA while long-term data are lacking. Most of the short-term studies showed no significant difference between corticosteroids and hyaluronic acid in thumb-base OA, usually with a faster onset of pain relief in the corticosteroid group and a slower but greater (statistically insignificant) pain improvement in the HA group. The majority of studies in investigational agents were limited by small sample size, short-term follow-up, and presence of serious side effects. In addition, we reported higher accuracy rates of drug administrations under imaging guidance than landmark guidance (blind method), and then briefly describe challenges for the long-term efficacy and prospects of IA therapeutics.

PMID:36633823 | DOI:10.1007/s40266-022-00994-3

Rheumatol Ther. 2023 Jan 12. doi: 10.1007/s40744-022-00522-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Biologic disease-modifying anti-rheumatic drugs (bDMARDs), including certolizumab pegol (CZP), are effective treatment options for the management of non-radiographic spondyloarthritis (nr-axSpA). In the absence of head-to-head comparisons in nr-axSpA, we conducted a systematic literature review (SLR) and indirect treatment comparison (ITC) to better understand the comparative efficacy of CZP vs. other bDMARDs.

METHODS: Literature searches were conducted in October 2020 in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials in patients with nr-axSpA who had failed at least one non-steroidal anti-inflammatory drug and were treated with bDMARDs. Outcomes of interest included the Assessment of Spondyloarthritis international Society (ASAS), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI) and Disease Activity Index (BASDAI), and spinal pain score. Comparative efficacy was examined using a series of Bucher ITCs in subgroups matched by prior exposure to bDMARDs, disease duration, baseline C-reactive protein (CRP) levels/magnetic resonance imaging (MRI) status, and timepoints, to ensure comparability between studies.

RESULTS: At 12-16 weeks, treatment with CZP was significantly more likely to achieve ASAS20/40 response and ASDAS-inactive disease status vs. etanercept (ETN), ixekizumab (IXE), and secukinumab (SEC). CZP showed statistically significant improvement in BASDAI, BASFI, and total spine pain score over adalimumab (ADA), ETN, and IXE, and in BASFI over SEC. Among patients with objective signs of inflammation (OSI; elevated CRP levels and/or inflammation on MRI at baseline), CZP had a statistically significant advantage over ETN and SEC (with or without loading dose) in achieving ASAS40, whereas the comparisons with other bDMARDs did not show any statistically significant differences.

CONCLUSION: In the overall matched population, CZP performed significantly better than most comparators in improving the clinical outcomes. Among patients with OSI, CZP was found to be superior to SEC (in the MRI-/CRP + and MRI + /CRP- subgroups) and ETN (in the MRI + /CRP- subgroup) and it was comparable to golimumab and IXE across the different OSI subgroups.

PMID:36633815 | DOI:10.1007/s40744-022-00522-0

Neuropsychol Rev. 2023 Jan 12. doi: 10.1007/s11065-022-09574-z. Online ahead of print.

ABSTRACT

Executive Functions are a set of interrelated, top-down processes essential for adaptive goal-directed behaviour, frequently impaired across different neurodevelopmental disorders with variable degrees of severity. Many executive-function-training studies in children with neurodevelopmental disorders have focused on near effects, investigating post-treatment improvements on directly trained processes, while enhancements of skills not directly trained, defined as far effects, are less considered, albeit these could be extremely relevant for reducing the negative impact of a disorder’s core symptomatology. This systematic review and metanalysis aims to investigate the far effect outcomes after EF training in children with different types of neurodevelopmental disorders. 17 studies met the inclusion criteria for the systematic review, while 15 studies were selected in the metanalysis. An overall statistically significant effect size was found in the majority of far effect outcome measures considered in the studies. In particular, trainings on executive functions determine significant far effects on daily life functioning (0.46, 95% CI: [0.05-0.87]) and clinical symptoms (0.33, 95% CI: [0.15-0.51]). Despite a high variability of the results, intensity, frequency and the laboratory/life contexts dimension seem to be the most influential variables in determining far effects. This systematic review and metanalysis highlights the need to measure far effects of executive function training in neurodevelopmental disorders, selecting treatments not only on directly targeted processes, but also according to far impacts on the functional weakness of the disorder.

PMID:36633797 | DOI:10.1007/s11065-022-09574-z