Tag: statistics

Transl Vis Sci Technol. 2023 Jul 3;12(7):4. doi: 10.1167/tvst.12.7.4.

ABSTRACT

PURPOSE: The purpose of this study was to assess in vivo regional variability in the densitometry parameters of corneal stroma and the modulating effect of age on those parameters using statistical characterization of optical coherence tomography (OCT) speckle.

METHODS: OCT imaging of central and peripheral cornea was performed in a group of 20 younger (24 to 30 years old) and 19 older (50 to 87 years old) subjects. The sample size was estimated using normal assumptions and previously reported data on speckle parameter variability. Statistical parameters of corneal OCT speckle were calculated in the regions of interest (ROI) encompassing central and peripheral stroma as well as taking into account their anterior and posterior subregions. Both parametric (Burr-2 parameters: α and k) and a nonparametric approach (contrast ratio [CR]) were considered. Two-way analysis of variance was used to test for differences in densitometry parameters with respect to ROI position and age.

RESULTS: Both approaches showed statistically significant differences within the ROI positions (all P < 0.001 for α, k, and CR) and age (P < 0.001, P = 0.002, and P = 0.003, for α, k, and CR, respectively) indicating substantial stromal asymmetry. Additionally, CR showed statistically significant differences between anterior and posterior subregions (P < 0.001).

CONCLUSIONS: Corneal OCT-based densitometry is inherently asymmetrical and are influenced by age. The results indicate that regional variability of stromal structure is not limited to the central and peripheral regions but that differences exist also between the nasal and temporal parts of the cornea.

TRANSLATIONAL RELEVANCE: The in vivo acquired parameters of corneal OCT speckle can be used to indirectly assess corneal structure.

PMID:37405797 | DOI:10.1167/tvst.12.7.4

JAMA Psychiatry. 2023 Jul 5. doi: 10.1001/jamapsychiatry.2023.2105. Online ahead of print.

ABSTRACT

IMPORTANCE: Face processing is foundational to human social cognition, is central to the hallmark features of autism spectrum disorder (ASD), and shapes neural systems and social behavior. Highly efficient and specialized, the face processing system is sensitive to inversion, demonstrated by reduced accuracy in recognition and altered neural response to inverted faces. Understanding at which mechanistic level the autistic face processing system may be particularly different, as measured by the face inversion effect, will improve overall understanding of brain functioning in autism.

OBJECTIVE: To synthesize data from the extant literature to determine differences of the face processing system in ASD, as measured by the face inversion effect, across multiple mechanistic levels.

DATA SOURCES: Systematic searches were conducted in the MEDLINE, Embase, Web of Science, and PubMed databases from inception to August 11, 2022.

STUDY SELECTION: Original research that reported performance-based measures of face recognition to upright and inverted faces in ASD and neurotypical samples were included for quantitative synthesis. All studies were screened by at least 2 reviewers.

DATA EXTRACTION AND SYNTHESIS: This systematic review and meta-analysis was conducted according to the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Multiple effect sizes were extracted from studies to maximize information gain and statistical precision and used a random-effects, multilevel modeling framework to account for statistical dependencies within study samples.

MAIN OUTCOMES AND MEASURES: Effect sizes were calculated as a standardized mean change score between ASD and neurotypical samples (ie, Hedges g). The primary outcome measure was performance difference between upright and inverted faces during face recognition tasks. Measurement modality, psychological construct, recognition demand, sample age, sample sex distribution, and study quality assessment scores were assessed as moderators.

RESULTS: Of 1768 screened articles, 122 effect sizes from 38 empirical articles representing data from 1764 individual participants (899 ASD individuals and 865 neurotypical individuals) were included in the meta-analysis. Overall, face recognition performance differences between upright and inverted faces were reduced in autistic individuals compared with neurotypical individuals (g = -0.41; SE = 0.11; 95% credible interval [CrI], -0.63 to -0.18). However, there was considerable heterogeneity among effect sizes, which were explored with moderator analysis. The attenuated face inversion effect in autistic individuals was more prominent in emotion compared with identity recognition (b = 0.46; SE = 0.26; 95% CrI, -0.08 to 0.95) and in behavioral compared with electrophysiological measures (b = 0.23; SE = 0.24; 95% CrI, -0.25 to 0.70).

CONCLUSIONS AND RELEVANCE: This study found that on average, face recognition in autism is less impacted by inversion. These findings suggest less specialization or expertise of the face processing system in autism, particularly in recognizing emotion from faces as measured in behavioral paradigms.

PMID:37405787 | DOI:10.1001/jamapsychiatry.2023.2105

JAMA Netw Open. 2023 Jul 3;6(7):e2321792. doi: 10.1001/jamanetworkopen.2023.21792.

ABSTRACT

IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical devices. Currently, there are no uniform guidelines set by the FDA to regulate AI- or ML-enabled medical devices, and discrepancies between FDA-approved indications for use and device marketing require articulation.

OBJECTIVE: To explore any discrepancy between marketing and 510(k) clearance of AI- or ML-enabled medical devices.

EVIDENCE REVIEW: This systematic review was a manually conducted survey of 510(k) approval summaries and accompanying marketing materials of devices approved between November 2021 and March 2022, conducted between March and November 2022, following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Analysis focused on the prevalence of discrepancies between marketing and certification material for AI/ML enabled medical devices.

FINDINGS: A total of 119 FDA 510(k) clearance summaries were analyzed in tandem with their respective marketing materials. The devices were taxonomized into 3 individual categories of adherent, contentious, and discrepant devices. A total of 15 devices (12.61%) were considered discrepant, 8 devices (6.72%) were considered contentious, and 96 devices (84.03%) were consistent between marketing and FDA 510(k) clearance summaries. Most devices were from the radiological approval committees (75 devices [82.35%]), with 62 of these devices (82.67%) adherent, 3 (4.00%) contentious, and 10 (13.33%) discrepant; followed by the cardiovascular device approval committee (23 devices [19.33%]), with 19 of these devices (82.61%) considered adherent, 2 contentious (8.70%) and 2 discrepant (8.70%). The difference between these 3 categories in cardiovascular and radiological devices was statistically significant (P < .001).

CONCLUSIONS AND RELEVANCE: In this systematic review, low adherence rates within committees were observed most often in committees with few AI- or ML-enabled devices. and discrepancies between clearance documentation and marketing material were present in one-fifth of devices surveyed.

PMID:37405771 | DOI:10.1001/jamanetworkopen.2023.21792

JAMA Netw Open. 2023 Jul 3;6(7):e2321805. doi: 10.1001/jamanetworkopen.2023.21805.

ABSTRACT

IMPORTANCE: Youths incarcerated in adult correctional facilities are exposed to a variety of adverse circumstances that could diminish psychological and physical health, potentially leading to early mortality.

OBJECTIVE: To evaluate whether being incarcerated in an adult correctional facility as a youth was associated with mortality between 18 and 39 years of age.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study relied on longitudinal data collected from 1997 to 2019 as part of the National Longitudinal Survey of Youth-1997, a nationally representative sample of 8984 individuals born in the United States between January 1, 1980, and December 1, 1984. The data analyzed for the current study were derived from annual interviews between 1997 and 2011 and interviews every other year from 2013 to 2019 (19 interviews in total). Participants were limited to respondents aged 17 years or younger during the 1997 interview and alive during their 18th birthday (8951 individuals; >99% of the original sample). Statistical analysis was performed from November 2022 to May 2023.

INTERVENTION: Incarceration in an adult correctional facility before the age of 18 years compared with being arrested before the age of 18 years or never arrested or incarcerated before the age of 18 years.

MAIN OUTCOMES AND MEASURES: The main outcome for the study was age at mortality between 18 and 39 years of age.

RESULTS: The sample of 8951 individuals included 4582 male participants (51%), 61 American Indian or Alaska Native participants (1%), 157 Asian participants (2%), 2438 Black participants (27%), 1895 Hispanic participants (21%), 1065 participants of other race (12%), and 5233 White participants (59%). A total of 225 participants (3%) died during the study period, with a mean (SD) age at death of 27.7 (5.9) years. Incarceration in an adult correctional facility before the age of 18 years was associated with an increased risk of earlier mortality between 18 and 39 years of age compared with individuals who were never arrested or incarcerated before the age of 18 years (time ratio, 0.67; 95% CI, 0.47-0.95). Being arrested before the age of 18 years was associated with an increased risk of earlier mortality between 18 and 39 years of age when compared with individuals who were never arrested or incarcerated before the age of 18 years (time ratio, 0.82; 95% CI, 0.73-0.93).

CONCLUSIONS AND RELEVANCE: In this cohort study of 8951 youths, the survival model suggested that being incarcerated in an adult correctional facility may be associated with an increased risk of early mortality between 18 and 39 years of age.

PMID:37405770 | DOI:10.1001/jamanetworkopen.2023.21805

JAMA Psychiatry. 2023 Jul 5. doi: 10.1001/jamapsychiatry.2023.2157. Online ahead of print.

ABSTRACT

IMPORTANCE: Possible associations between stimulant treatment of attention-deficit/hyperactivity disorder (ADHD) and subsequent substance use remain debated and clinically relevant.

OBJECTIVE: To assess the association of stimulant treatment of ADHD with subsequent substance use using the Multimodal Treatment Study of ADHD (MTA), which provides a unique opportunity to test this association while addressing methodologic complexities (principally, multiple dynamic confounding variables).

DESIGN, SETTING, AND PARTICIPANTS: MTA was a multisite study initiated at 6 sites in the US and 1 in Canada as a 14-month randomized clinical trial of medication and behavior therapy for ADHD but transitioned to a longitudinal observational study. Participants were recruited between 1994 and 1996. Multi-informant assessments included comprehensively assessed demographic, clinical (including substance use), and treatment (including stimulant treatment) variables. Children aged 7 to 9 years with rigorously diagnosed DSM-IV combined-type ADHD were repeatedly assessed until a mean age of 25 years. Analysis took place between April 2018 and February 2023.

EXPOSURE: Stimulant treatment of ADHD was measured prospectively from baseline for 16 years (10 assessments) initially using parent report followed by young adult report.

MAIN OUTCOMES AND MEASURES: Frequency of heavy drinking, marijuana use, daily cigarette smoking, and other substance use were confidentially self-reported with a standardized substance use questionnaire.

RESULTS: A total of 579 children (mean [SD] age at baseline, 8.5 [0.8] years; 465 [80%] male) were analyzed. Generalized multilevel linear models showed no evidence that current (B [SE] range, -0.62 [0.55] to 0.34 [0.47]) or prior stimulant treatment (B [SE] range, -0.06 [0.26] to 0.70 [0.37]) or their interaction (B [SE] range, -0.49 [0.70] to 0.86 [0.68]) were associated with substance use after adjusting for developmental trends in substance use and age. Marginal structural models adjusting for dynamic confounding by demographic, clinical, and familial factors revealed no evidence that more years of stimulant treatment (B [SE] range, -0.003 [0.01] to 0.04 [0.02]) or continuous, uninterrupted stimulant treatment (B [SE] range, -0.25 [0.33] to -0.03 [0.10]) were associated with adulthood substance use. Findings were the same for substance use disorder as outcome.

CONCLUSIONS AND RELEVANCE: This study found no evidence that stimulant treatment was associated with increased or decreased risk for later frequent use of alcohol, marijuana, cigarette smoking, or other substances used for adolescents and young adults with childhood ADHD. These findings do not appear to result from other factors that might drive treatment over time and findings held even after considering opposing age-related trends in stimulant treatment and substance use.

PMID:37405756 | DOI:10.1001/jamapsychiatry.2023.2157

Acc Chem Res. 2023 Jul 5. doi: 10.1021/acs.accounts.3c00247. Online ahead of print.

ABSTRACT

ConspectusThe class of reactions now known as Minisci reactions is broadly defined as the addition of nucleophilic carbon-based radicals to basic heteroarenes with subsequent rearomatization to form a new carbon-carbon bond. Since the pioneering work of Minisci in the 1960s and 1970s, these reactions are now widely used in medicinal chemistry due to the ubiquity of basic heterocycles in druglike molecules. One of the long-standing challenges of Minisci chemistry has been that of regioselectivity due to the mixtures of positional isomers commonly obtained on many substrates if there is a choice between similarly activated sites. At the outset of the work described herein, we hypothesized that it may be possible to tackle this using a catalytic strategy whereby a bifunctional Brønsted acid catalyst simultaneously activates the heteroarene and engages attractive non-covalent interactions with the incoming nucleophile, resulting in a proximal attack. Using chiral BINOL-derived phosphoric acids, we not only were able to achieve this goal of regiocontrol but also discovered that we could control the absolute stereochemistry at the new stereocenter formed when prochiral α-amino radicals were employed. At the time, this discovery was unprecedented in the context of Minisci reactions.This Account details the discovery of this protocol and the further development, expansion, and investigations into the mechanism that we have carried out since then, several in collaboration with other research groups. Collaborative efforts have involved an expansion of the scope to diazines guided by multivariate statistical analysis through the development of a predictive model (collaboration with Sigman). Also, a mechanistic study involving detailed DFT analysis (collaboration with Goodman and Ermanis) unveiled the selectivity-determining step as being the deprotonation of a key cationic radical intermediate by the associated chiral phosphate anion. We have additionally carried out a number of synthetic developments of the protocol such as removing the need to prefunctionalize the radical nucleophile; hydrogen-atom transfer can be used to enable a formal coupling of two C-H bonds to form a C-C bond while retaining high enantio- and regioselectivity. Most recently, we have been able to expand the protocol so that α-hydroxy radicals can be used: until this point, all examples had concerned α-amino radicals. Again, HAT was used to generate the α-hydroxy radicals, and DFT studies carried out in collaboration (Ermanis) provided mechanistic insights.Since our original report, there have appeared a number of exciting developments from other research groups whereby the protocol has been applied to new substrates or using different precursors to generate the requisite α-amino radical. There have also been several examples in which alternative photocatalyst systems have been used to reduce the redox-active esters in the original enantioselective Minisci protocol. While primarily an Account, these contributions from other research groups will be covered briefly for context toward the end of the article.

PMID:37405731 | DOI:10.1021/acs.accounts.3c00247

JAMA Surg. 2023 Jul 5. doi: 10.1001/jamasurg.2023.2403. Online ahead of print.

ABSTRACT

IMPORTANCE: Cannabis use is growing in the US and is increasingly perceived as harmless. However, the perioperative impact of cannabis use remains uncertain.

OBJECTIVE: To assess whether cannabis use disorder is associated with increased morbidity and mortality after major elective, inpatient, noncardiac surgery.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, population-based, matched cohort study used data from the National Inpatient Sample for adult patients aged 18 to 65 years who underwent major elective inpatient surgery (including cholecystectomy, colectomy, inguinal hernia repair, femoral hernia repair, mastectomy, lumpectomy, hip arthroplasty, knee arthroplasty, hysterectomy, spinal fusion, and vertebral discectomy) from January 2016 to December 2019. Data were analyzed from February to August 2022.

EXPOSURE: Cannabis use disorder, as defined by the presence of specific International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnostic codes.

MAIN OUTCOME AND MEASURES: The primary composite outcome was in-hospital mortality and 7 major perioperative complications (myocardial ischemia, acute kidney injury, stroke, respiratory failure, venous thromboembolism, hospital-acquired infection, and surgical procedure-related complications) based on ICD-10 discharge diagnosis codes. Propensity score matching was performed to create a 1:1 matched cohort that was well balanced with respect to covariates, which included patient comorbidities, sociodemographic factors, and procedure type.

RESULTS: Among 12 422 hospitalizations, a cohort of 6211 patients with cannabis use disorder (median age, 53 years [IQR, 44-59 years]; 3498 [56.32%] male) were matched with 6211 patients without cannabis use disorder for analysis. Cannabis use disorder was associated with an increased risk of perioperative morbidity and mortality compared with hospitalizations without cannabis use disorder in adjusted analysis (adjusted odds ratio, 1.19; 95% CI, 1.04-1.37; P = .01). The outcome occurred more frequently in the group with cannabis use disorder (480 [7.73%]) compared with the unexposed group (408 [6.57%]).

CONCLUSIONS AND RELEVANCE: In this cohort study, cannabis use disorder was associated with a modest increased risk of perioperative morbidity and mortality after major elective, inpatient, noncardiac surgery. In the context of increasing cannabis use rates, our findings support preoperative screening for cannabis use disorder as a component of perioperative risk stratification. However, further research is needed to quantify the perioperative impact of cannabis use by route and dosage and to inform recommendations for preoperative cannabis cessation.

PMID:37405729 | DOI:10.1001/jamasurg.2023.2403

Minerva Cardiol Angiol. 2023 Jul 5. doi: 10.23736/S2724-5683.23.06345-7. Online ahead of print.

ABSTRACT

BACKGROUND: Despite progress during the last decades, patients with coronary artery disease (CAD) remain with a high residual risk due to multiple reasons. Optimal medical treatment (OMT) provides a decrease of recurrent ischemic events after acute coronary syndrome (ACS). Therefore, treatment adherence results crucial to reduce further outcomes after the index event. No recent data are available in Argentinian population; the main objective of our study was to evaluate the adherence at 6 and 15 months in post non-ST elevation acute coronary syndrome (NST-ACS) consecutive patients. Secondary objective was to evaluate the relationship of adherence with 15-month events.

METHODS: A prespecified sub-analysis in the prospective registry Buenos Aires I was performed. The adherence was evaluated using the modified Morisky-Green Scale.

RESULTS: A number of 872 patients had information about adherence profile. Of them 76.4% were classified as adherents at month 6 and 83.6% at 15 (P=0.06). We did not find any difference in baseline characteristic between the adherent and non-adherent patients at 6 months. The adjusted analysis showed that non-adherent patients had a rate of ischemic events at 15^th month of 20% (27/135) vs. 11.5% (52/452) in adherent patients (P=0.001). The bleeding events defined were of 3.6% in the non-adherent group vs. 5% in the adherent group without a statistical difference (P=0.238).

CONCLUSIONS: Adherence to treatment is still a major issue as almost 25% of patients should be considered as non-adherent to OMT. No clinical predictor of this phenomenon was identified but our criteria were not exhaustive. Good adherence to treatment was highly associated to a reduction of ischemic events, whereas no impact on bleeding events was found. These data support a better network and collaboration with shared decision between healthcare professionals with patients and family members to improve acceptance and adherence to optimal medical strategies.

PMID:37405714 | DOI:10.23736/S2724-5683.23.06345-7

Minerva Cardiol Angiol. 2023 Jul 5. doi: 10.23736/S2724-5683.23.06139-2. Online ahead of print.

ABSTRACT

BACKGROUND: Fast acting insulin analogues are known to improve arterial stiffness. The combination of metformin with insulin represents a widely used therapeutic strategy in diabetes. We hypothesized that insulin treatment in patients with type 2 diabetes (T2D) with long-acting, fast-acting or basal bolus insulin as an add-on to metformin would provide additional improvement of arterial stiffness.

METHODS: The INSUlin Regimens and VASCular Functions (INSUVASC) study is a pilot, randomized, open label three-arms study that included 42 patients with type 2 diabetes (T2D) in primary prevention, after a failure to oral antidiabetic agents. Arterial stiffness measurements were performed at fasting and after a standardized breakfast. During the first visit (V1) pre-randomization, participants took only metformin to perform the tests. The same tests were repeated after 4 weeks of insulin treatment during the second visit (V2).

RESULTS: Data were available for final analysis in 40 patients, with a mean age of 53.6±9.7 years and a mean duration of diabetes of 10.6±5.6 years. Twenty-one were females (52.5%), hypertension and dyslipidemia were present in 18 (45%) and 17 patients (42.5%), respectively. After insulin treatment, the metabolic control was associated to a decrease in oxidative stress and improvement of endothelial functions, with a post prandial diastole duration increased and a decrease of the peripheral arterial stiffness, with a better post prandial pulse pressure ratio and ejection duration after insulin. In hypertensive patients, insulin treatment provided positive effects by decreasing the pulse wave velocity and improving reflection time.

CONCLUSIONS: A short time treatment by insulin in addition to metformin improved myocardial perfusion. Moreover, insulin treatment in hypertensive patients provides a better hemodynamic profile in large arteries.

PMID:37405711 | DOI:10.23736/S2724-5683.23.06139-2

Health Educ Res. 2023 Jul 5:cyad025. doi: 10.1093/her/cyad025. Online ahead of print.

ABSTRACT

The delivery of comprehensive sexuality education to adolescents at school is recognized as a long-term strategy to support adolescent health. Suboptimal sexual and reproductive health (SRH) outcomes among South African adolescents necessitate the ongoing development and optimization of SRH education and promotion models. We conducted a cluster-randomized controlled trial amongst secondary schools (n = 38) in Cape Town, South Africa, to evaluate a sport-based, near-peer-led SRH curriculum, SKILLZ, amongst female learners (n = 2791). Biomedical (sexually transmitted infections [STIs], human immunodeficiency virus [HIV] and pregnancy) and socio-behavioural (social support, gender norms and self-concept) outcomes were assessed pre and post intervention. Attendance at SKILLZ was low and intervention participants did not show an improvement in SRH outcomes, with HIV and pregnancy incidence remaining stable and STI prevalence remaining high and increasing in both control and intervention arms. Although evidence of positive socio-behavioural measures was present at baseline, participants with high attendance showed further improvement in positive gender norms. SKILLZ did not demonstrate the capacity to significantly impact clinical SRH outcomes. Modest improvements in outcomes amongst high attenders suggest that the impact may be possible with improved attendance; however, in the absence of optimal attendance, alternative intervention strategies may be required to improve SRH outcomes amongst adolescents.

PMID:37405698 | DOI:10.1093/her/cyad025