Predicting response time on self-report rating scale assessments of noncognitive constructs.

Methodological studies of response time on noncognitive assessments have separately demonstrated the relevance of content trait level and response styles as predictive factors. In this paper we examine the simultaneous relevance of both factors as well as the potential for omitted predictor bias when ignoring either factor. Using response time data from several different noncognitive assessments, we demonstrate how a multilevel regression model that attends simultaneously to content and response style factors leads to consistent findings that support the simultaneous relevance of both factors. The average effects of response style consistently emerge as stronger, although also show greater respondent-level variability, possibly due to the multiple different underlying causes of response style behavior. Some implications for the use of response times in noncognitive measurement are considered.

The Relationship of COVID-19 Vaccination with Mortality Among 86,732 Hospitalized Patients: Subpopulations, Patient Factors, and Changes over Time.

BACKGROUND: Information on COVID-19 vaccination effects on mortality among patients hospitalized with COVID-19 could inform vaccination outreach efforts and increase understanding of patient risk. OBJECTIVE: Determine the associations of vaccination status with mortality in adult patients hospitalized with COVID-19. DESIGN: This retrospective cohort study assessed the characteristics and mortality rates of adult patients hospitalized with COVID-19 across 21 healthcare systems in the USA from January 1, 2021, to January 31, 2022. PARTICIPANTS: Adult patients admitted to participating hospitals who had COVID-19 diagnoses and/or positive PCR tests and completed their hospital stay via discharge or death. MAIN MEASURE: In-hospital mortality vs. discharge (outcome) and patient age, sex, race, ethnicity, BMI, insurance status, comorbidities, and vaccination status extracted from the electronic health record (EHR). KEY RESULTS: Of 86,732 adult patients hospitalized with COVID-19, 45,082 (52%) were female, mean age was 60 years, 20,800 (24%) were Black, and 22,792 (26.3%) had one or more COVID-19 vaccinations. Statistically adjusted mortality rates for unvaccinated and vaccinated patients were 8.3% (95% CI, 8.1-8.5) and 5.1% (95% CI, 4.8-5.4) respectively (7.9% vs. 4.5% with no immune compromise). Vaccination was associated with especially large reductions in mortality for obese (OR = 0.67; 95% CI 0.56-0.80) and severely obese (OR = 0.52; 95% CI, 0.41-0.67) patients and for older patients (OR = 0.99; 95% CI, 0.98-0.99). Mortality likelihood was higher later in the study period (August 2021-January 31, 2022) than earlier (January 1, 2021-July 30, 2021) (OR = 1.10; 95% CI = 1.04-1.17) and increased significantly for vaccinated patients from 4.6% (95% CI, 3.9-5.2%) to 6.5% (95% CI, 6.2-6.9%). CONCLUSIONS: Patients vaccinated for COVID-19 had reduced mortality, especially for obese/severely obese and older individuals. Vaccination's protective effect against mortality declined over time and hospitalized obese and older individuals may derive especially great benefit from prior vaccination against SARS-CoV-2.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Unipolar IRT and the Author Recognition Test (ART).

Item response theory (IRT) analyses are often used to evaluate measurement error in educational and psychological test instruments. In such contexts, the latent traits/proficiencies are typically assumed normally distributed and a cumulative normal/logistic measurement link function is applied. Such choices are consistent with constructs that are viewed as bipolar in nature and play a critical role in defining the latent proficiency metric against which the measurement error in the test is evaluated. Recently, alternative models that portray the construct as unipolar have been highlighted as being more appropriate for certain psychopathology and personality constructs. In this paper we extend consideration of unipolar IRT models for a recognition task measure, using several example datasets from various versions of the Author Recognition Test (ART), a measure of print exposure. We show how the decision between unipolar versus bipolar IRT modeling has substantial implications for the quantification and interpretation of measurement error in the ART. In sharp contrast to prior bipolar IRT analyses of the ART, under unipolar IRT measurement error in the ART is minimized at low levels of latent print exposure, and increases as latent print exposure increases. Implications for consideration of unipolar IRT with other constructs and measures (e.g., vocabulary, specialized forms of knowledge) that reflect a similar type of response process are considered in the discussion.

Data Missing Not at Random in Mobile Health Research: Assessment of the Problem and a Case for Sensitivity Analyses.

BACKGROUND: Missing data are common in mobile health (mHealth) research. There has been little systematic investigation of how missingness is handled statistically in mHealth randomized controlled trials (RCTs). Although some missing data patterns (ie, missing at random [MAR]) may be adequately addressed using modern missing data methods such as multiple imputation and maximum likelihood techniques, these methods do not address bias when data are missing not at random (MNAR). It is typically not possible to determine whether the missing data are MAR. However, higher attrition in active (ie, intervention) versus passive (ie, waitlist or no treatment) conditions in mHealth RCTs raise a strong likelihood of MNAR, such as if active participants who benefit less from the intervention are more likely to drop out. OBJECTIVE: This study aims to systematically evaluate differential attrition and methods used for handling missingness in a sample of mHealth RCTs comparing active and passive control conditions. We also aim to illustrate a modern model-based sensitivity analysis and a simpler fixed-value replacement approach that can be used to evaluate the influence of MNAR. METHODS: We reanalyzed attrition rates and predictors of differential attrition in a sample of 36 mHealth RCTs drawn from a recent meta-analysis of smartphone-based mental health interventions. We systematically evaluated the design features related to missingness and its handling. Data from a recent mHealth RCT were used to illustrate 2 sensitivity analysis approaches (pattern-mixture model and fixed-value replacement approach). RESULTS: Attrition in active conditions was, on average, roughly twice that of passive controls. Differential attrition was higher in larger studies and was associated with the use of MAR-based multiple imputation or maximum likelihood methods. Half of the studies (18/36, 50%) used these modern missing data techniques. None of the 36 mHealth RCTs reviewed conducted a sensitivity analysis to evaluate the possible consequences of data MNAR. A pattern-mixture model and fixed-value replacement sensitivity analysis approaches were introduced. Results from a recent mHealth RCT were shown to be robust to missing data, reflecting worse outcomes in missing versus nonmissing scores in some but not all scenarios. A review of such scenarios helps to qualify the observations of significant treatment effects. CONCLUSIONS: MNAR data because of differential attrition are likely in mHealth RCTs using passive controls. Sensitivity analyses are recommended to allow researchers to assess the potential impact of MNAR on trial results.

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial.

Importance: Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness. Objective: To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration). Design, Settings, and Participants: Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. Interventions: All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). Main Outcomes and Measures: The primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. Results: Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, -0.4% [95% CI, -5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, -4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups. Conclusions and Relevance: Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration. Trial Registration: ClinicalTrials.gov Identifier: NCT03176784.

Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse.

INTRODUCTION: Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse. METHODS: Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse. RESULTS: By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-"lapse" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks. CONCLUSIONS: In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts. IMPLICATIONS: This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01120704.

Corner vowels in males and females ages 4 to 20 years: Fundamental and F1-F4 formant frequencies.

The purpose of this study was to determine the developmental trajectory of the four corner vowels' fundamental frequency (fo) and the first four formant frequencies (F1-F4), and to assess when speaker-sex differences emerge. Five words per vowel, two of which were produced twice, were analyzed for fo and estimates of the first four formants frequencies from 190 (97 female, 93 male) typically developing speakers ages 4-20 years old. Findings revealed developmental trajectories with decreasing values of fo and formant frequencies. Sex differences in fo emerged at age 7. The decrease of fo was larger in males than females with a marked drop during puberty. Sex differences in formant frequencies appeared at the earliest age under study and varied with vowel and formant. Generally, the higher formants (F3-F4) were sensitive to sex differences. Inter- and intra-speaker variability declined with age but had somewhat different patterns, likely reflective of maturing motor control that interacts with the changing anatomy. This study reports a source of developmental normative data on fo and the first four formants in both sexes. The different developmental patterns in the first four formants and vowel-formant interactions in sex differences likely point to anatomic factors, although speech-learning phenomena cannot be discounted.

Extreme Response Style and the Measurement of Intra-Individual Variability in Affect.

Extreme response style (ERS) has the potential to bias the measurement of intra-individual variability in psychological constructs. This paper explores such bias through a multilevel extension of a latent trait model for modeling response styles applied to repeated measures rating scale data. Modeling responses to multi-item scales of positive and negative affect collected from smokers at clinic visits following a smoking cessation attempt revealed considerable ERS bias in the intra-individual sum score variances. In addition, simulation studies suggest the magnitude and direction of bias due to ERS is heavily dependent on the mean affect level, supporting a model-based approach to the study and control of ERS effects. Application of the proposed model-based adjustment is found to improve intra-individual variability as a predictor of smoking cessation.

Measurement and control of bias in patient reported outcomes using multidimensional item response theory.

BACKGROUND: Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can seriously bias the estimation of constructs assessed by the scale. A well-documented disadvantage of self-report measures is their sensitivity to response style (RS) effects such as the respondent's tendency to select the extremes of a rating scale. Although the biasing effect of extreme responding on constructs measured by self-reported tools has been widely acknowledged and studied across disciplines, little attention has been given to the development and systematic application of methodologies to assess and control for this effect in PRO measures. METHODS: We review the methodological approaches that have been proposed to study extreme RS effects (ERS). We applied a multidimensional item response theory model to simultaneously estimate and correct for the impact of ERS on trait estimation in a PRO instrument. Model estimates were used to study the biasing effects of ERS on sum scores for individuals with the same amount of the targeted trait but different levels of ERS. We evaluated the effect of joint estimation of multiple scales and ERS on trait estimates and demonstrated the biasing effects of ERS on these trait estimates when used as explanatory variables. RESULTS: A four-dimensional model accounting for ERS bias provided a better fit to the response data. Increasing levels of ERS showed bias in total scores as a function of trait estimates. The effect of ERS was greater when the pattern of extreme responding was the same across multiple scales modeled jointly. The estimated item category intercepts provided evidence of content independent category selection. Uncorrected trait estimates used as explanatory variables in prediction models showed downward bias. CONCLUSIONS: A comprehensive evaluation of the psychometric quality and soundness of PRO assessment measures should incorporate the study of ERS as a potential nuisance dimension affecting the accuracy and validity of scores and the impact of PRO data in clinical research and decision making.

Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial.

IMPORTANCE: Smoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality. OBJECTIVE: To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates. DESIGN, SETTING, AND PARTICIPANTS: Three-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization. INTERVENTIONS: Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n = 241); (2) varenicline only (including 1 prequit week; n = 424); and (3) C-NRT (nicotine patch + nicotine lozenge; n = 421). Six counseling sessions were offered. MAIN OUTCOMES AND MEASURES: The primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52. RESULTS: Among 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion. CONCLUSIONS AND RELEVANCE: Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks. The results raise questions about the relative effectiveness of intense smoking pharmacotherapies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01553084.

Risk and resilience in preterm children at age 6.

Children born preterm are at risk for experiencing significant deleterious developmental outcomes throughout their childhood and adolescence. However, individual variation and resilience are hallmarks of the preterm population. The present study examined pathways to resilience across multiple domains (e.g., social activities, peer relations, attention-deficit/hyperactivity disorder symptomology, externalizing and internalizing behavior, and sleep quality) as children born preterm reached school age. The study also examined early child and family predictors of resilience. Using a prospective longitudinal design, 173 infants born preterm and without significant neurological complications were assessed at five time points: neonatal intensive care unit discharge, 9 months, 16 months, 24 months, and 6 years. Three pathways of adaptation emerged at 6 years: children who were resilient, those who remained at-risk, and children who exhibited significant difficulties. Resilient children were less likely to have experienced negative parenting at 9 and 16 months, more likely to delay gratification at 24 months, and more likely to experience neonatal health complications than nonresilient children.

Cortical mechanisms of across-ear speech integration investigated using functional near-infrared spectroscopy (fNIRS).

This study aimed to investigate integration of alternating speech, a stimulus which classically produces a V-shaped speech intelligibility function with minimum at 2-6 Hz in typical-hearing (TH) listeners. We further studied how degraded speech impacts intelligibility across alternating rates (2, 4, 8, and 32 Hz) using vocoded speech, either in the right ear or bilaterally, to simulate single-sided deafness with a cochlear implant (SSD-CI) and bilateral CIs (BiCI), respectively. To assess potential cortical signatures of across-ear integration, we recorded activity in the bilateral auditory cortices (AC) and dorsolateral prefrontal cortices (DLPFC) during the task using functional near-infrared spectroscopy (fNIRS). For speech intelligibility, the V-shaped function was reproduced only in the BiCI condition; TH (with ceiling scores) and SSD-CI conditions had significantly higher scores across all alternating rates compared to the BiCI condition. For fNIRS, the AC and DLPFC exhibited significantly different activity across alternating rates in the TH condition, with altered activity patterns in both regions in the SSD-CI and BiCI conditions. Our results suggest that degraded speech inputs in one or both ears impact across-ear integration and that different listening strategies were employed for speech integration manifested as differences in cortical activity across conditions.

Evidence for Bidirectional, Cross-Lagged Associations Between Alliance and Psychological Distress in an Unguided Mobile-Health Intervention.

Bidirectional associations between changes in symptoms and alliance are established for in-person psychotherapy. Alliance may play an important role in promoting engagement and effectiveness within unguided mobile health (mHealth) interventions. Using models disaggregating alliance and psychological distress into within- and between-person components (random intercept cross-lagged panel model), we report bidirectional associations between alliance and distress over the course of a 4-week smartphone-based meditation intervention (n=302, 80.0% elevated depression/anxiety). Associations were stable across time with effect sizes similar to those observed for psychotherapy (ßs=-.13 to -.14 and -.09 to -.10, for distress to alliance and alliance to distress, respectively). Alliance may be worth measuring to improve the acceptability and effectiveness of mHealth tools. Further empirical and theoretical work characterizing the role and meaning of alliance in unguided mHealth is warranted.

Does it matter how meditation feels? An experience sampling study.

OBJECTIVE: Meditation apps are the most widely used mental health apps. The precise mechanisms underlying their effects remain unclear. In particular, the degree to which affect experienced during meditation is associated with outcomes has not been established. METHOD: We used the meditation app arm of a recently completed randomized controlled trial comparing a self-guided meditation app (Healthy Minds Program) to a waitlist control. Predominantly distressed public school employees (n = 243, 80.9% with clinically elevated depression and/or anxiety) reported positive and negative affect during meditation practice. Data were analyzed using two-level multivariate latent growth curve models (observations nested within participants) that simultaneously attended to both positive and negative affect. We examined whether positive and negative affect during meditation changed over time and whether these changes were associated with changes in psychological distress (parent trial's preregistered primary outcome) at posttest or 3-month follow-up. RESULTS: On average, participants reported decreased negative affect but no change in positive affect during meditation over time. Increased positive affect and decreased negative affect during meditation were associated with improvements in distress at posttest and follow-up. Change in positive affect was a stronger predictor of distress at follow-up than change in negative affect. CONCLUSIONS: Despite notions embedded within mainstream mindfulness meditation training that deemphasize the importance of the affective experience of practice (i.e., nonjudgmental awareness of present moment experience, regardless of valence), results indicate that these experiences contain signals associated with outcomes. Monitoring affect during meditation may be worthwhile to guide intervention delivery (i.e., measurement-based care, precision medicine). (PsycInfo Database Record (c) 2024 APA, all rights reserved).

What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments.

AIM: To compare effects of three post-relapse interventions on smoking abstinence. DESIGN: Sequential three-phase multiple assignment randomized trial (SMART). SETTING: Eighteen Wisconsin, USA, primary care clinics. PARTICIPANTS: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. INTERVENTIONS: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini-lozenges + encouragement to quit starting 1 month post-randomization (preparation); (2) repeated encouragement to quit starting immediately post-randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini-lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. MEASUREMENTS: The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7-day point-prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. FINDINGS: Neither skill training nor supportive counseling (each on versus off) increased 14-month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14-month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = -1.8-5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5-6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7-8.9%, OR = 3.5, 95% CI = 1.0-12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. CONCLUSIONS: Among people interested in quitting smoking, immediate encouragement post-relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re-engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy.

Tobacco Quitline Retreatment Interventions Among Adults With Socioeconomic Disadvantage: A Factorial Randomized Clinical Trial.

Importance: A single round of standard tobacco quitline treatment may not be sufficient to sustain abstinence, particularly among people experiencing socioeconomic disadvantage. Adaptive retreatment may help more individuals with socioeconomic disadvantage achieve abstinence and reduce disparities in smoking cessation outcomes. Objective: To evaluate 4 evidence-based strategies for adults with limited education, no insurance, or Medicaid eligibility who continued smoking after quitline treatment. Design, Setting, and Participants: A factorial randomized clinical trial with 4 factors adapting quitline strategies was conducted for participants enrolled from June 7, 2018, to January 25, 2023, with 6-month follow-up. Adults using the Wisconsin Tobacco Quit Line who were smoking cigarettes 3 to 6 months after prior quitline treatment who were uninsured, Medicaid insured, or had no more than a high school education were included. Interventions: Quitline retreatment strategies were (1) increased counseling intensity (4 calls vs 1 call), (2) increased nicotine replacement therapy intensity (4 weeks of combination nicotine patch plus nicotine lozenge vs 2 weeks of nicotine patch), (3) text-message support (National Cancer Institute SmokefreeTXT program vs none), and (4) financial incentives for engagement in counseling and SmokefreeTXT ($30/call and/or 6-week SmokefreeTXT retention vs no incentives). Main Outcomes and Measures: Primary outcome was 7-day point-prevalence biochemically confirmed abstinence 26 weeks after the target quit day. Intention-to-treat analysis was performed. Results: Of 6019 people assessed for eligibility, 1316 (21.9%) participants were randomized (mean [SD] age, 53.1 [11.9] years; 760 [57.8%] women), and 919 (69.8%) provided final follow-up. Intention-to-treat analyses showed 162 participants (12.3%) had biochemically confirmed abstinence at 26 weeks (368 [28.0% self-reported abstinence]). There were no significant main effects for the primary outcome: 1 call (11.6% [77 of 662]) vs 4 calls (13.0% [85 of 654]) (odds ratio [OR], 1.04; 95% CI, 0.88-1.24), 2-week patch (11.2% [73 of 654]) vs 4-week combination nicotine replacement therapy (13.4% [89 of 662]) (OR, 1.12; 95% CI, 0.94-1.34), no SmokefreeTXT (13.4% [88 of 657]) vs SmokefreeTXT (11.2% [74 of 659]) (OR, 0.88; 95% CI, 0.74-1.05), and no financial incentives (12.8% [85 of 662]) vs financial incentives (11.8% [77 of 654]) (OR, 0.94; 95% CI, 0.78-1.11). Conclusions and Relevance: In this randomized clinical trial evaluating enhancements to tobacco quitlines for adults with socioeconomic disadvantage who were smoking after quitline treatment, none of the adaptive treatment strategies robustly improved long-term abstinence. Strategies are needed to enhance quitline retreatment effectiveness for adults with socioeconomic disadvantage. Trial Registration: ClinicalTrials.gov Identifier: NCT03538938.

Disparities in chronic myeloid leukemia survival by age, gender, and ethnicity in pre- and post-imatinib eras in the US.

BACKGROUND: Since May 2001, imatinib mesylate has become the first-line therapy for chronic myeloid leukemia (CML) but the survival pattern by age, sex, and ethnicity is not clear. MATERIAL AND METHODS: We analyzed the Surveillance, Epidemiology, and End Results (SEER*Stat) database to compare survival rates in CML among Caucasians, African-Americans (AA), and other races, and also within each race to see survival differences from the pre-imatinib (1973-2000) to post-imatinib eras (2002-2008). We used Z-tests in SEER*Stat to compare relative survival rates categorized by race, gender, and age groups (all ages, < 50, 50+ years). RESULTS: The three-year relative survival rates among Caucasians, AA, and other races in the pre-imatinib era were 44.9 ± 0.6%, 46.8 ± 1.8%, and 48.0 ± 2.2%, respectively, and in the post-imatinib era 64.4 ± 0.8%, 67.3 ± 2.4%, and 69.6 ± 1.6%, respectively. The relative survival increased from the pre-to post-imatinib era for all ethnic groups. In the post-imatinib era, three-year relative survival rates among young AA women were significantly lower (Z-value = -2.54, p = 0.011) than young Caucasian women, 80.5 ± 4.5% (n = 105) vs. 90.3 ± 1.4% (n = 589). CONCLUSIONS: The relative survival rates of CML patients have improved in the post-imatinib era. However, the improvement in survival rates has been modest in this population-based data compared to those reported from randomized trials. Improvement in survival among older patients is lower than in younger patients. Young (<50 years) AA women with CML had lower relative survival rates compared to young Caucasian women in the post-imatinib era.

Measuring exertion during caregiving of children and young adults with cerebral palsy who require assistance for mobility and self-care.

Our purpose was to compare objective and subjective measures of energy exertion during caregiving tasks. Participants were primary caregivers (N = 19) of children and young adults (aged 3 -22 years) with cerebral palsy (CP) who require assistance for mobility and self-care (67% classified in level V on the Gross Motor Function Classification System). Measures of exertion were collected during two caregiving tasks: (1) transfers and (2) dressing. Objective measures included volume of oxygen (V02), heart rate (HR), and the subjective measure was a rating of perceived exertion (Borg RPE). Controlling for baseline status, perceived exertion correlated with VO2 (0.43, p < .01) and HR (0.29, p < .01) during the tasks. Caregivers with high baseline HR and VO2, had high Borg RPE scores following a task. Correlations were found between HR and VO2 during caregiving tasks (0.63, p < .01). Patterns of association with caregiver and child characteristics were similar for VO2 and Borg RPE. Subjective measures of exertion appear to capture the strain of caregiving. Understanding a caregiver's perception of exertion can guide therapists in assessing the need for equipment, pharmacological, or respite interventions.

Relative Robustness of CDMs and (M)IRT in Measuring Growth in Latent Skills.

Previous studies have demonstrated evidence of latent skill continuity even in tests intentionally designed for measurement of binary skills. In addition, the assumption of binary skills when continuity is present has been shown to potentially create a lack of invariance in item and latent ability parameters that may undermine applications. In this article, we examine measurement of growth as one such application, and consider multidimensional item response theory (MIRT) as a competing alternative. Motivated by prior findings concerning the effects of skill continuity, we study the relative robustness of cognitive diagnostic models (CDMs) and (M)IRT models in the measurement of growth under both binary and continuous latent skill distributions. We find CDMs to be a less robust way of quantifying growth under misspecification, and subsequently provide a real-data example suggesting underestimation of growth as a likely consequence. It is suggested that researchers should regularly attend to the assumptions associated with the use of latent binary skills and consider (M)IRT as a potentially more robust alternative if unsure of their discrete nature.